Hydroxyzine Oral Capsule

Brand(s)
Vistaril
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Labs (2014-05-05)
Oldest Current Product
1968-11-15
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\HYDROXYZINE
FDAOB
ORAL\CAPSULE\HYDROXYZINE PAMOATE
SPL Active
ORAL\CAPSULE\HYDROXYZINE HYDROCHLORIDE
ORAL\CAPSULE\HYDROXYZINE HYDROCHLORIDE: HYDROXYZINE PAMOATE
ORAL\CAPSULE\HYDROXYZINE PAMOATE
SPL Moiety
ORAL\CAPSULE\HYDROXYZINE

product(s) by strength(s)

hydroxyzine pamoate 100 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005550324ANDABarr Laboratories Inc.1984-07-01HYDROXYZINE PAMOATEORALCAPSULEANDA08848806068fff-2e79-4721-bcc7-b0938aa20e7a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1430630251ANDAPd-Rx Pharmaceuticals, Inc.2011-09-01HYDROXYZINE PAMOATEORALCAPSULE005550324ANDA08848879c93c3a-167b-4394-841f-ee491b8815a2
2538080431ANDAState Of Florida Doh Central Pharmacy2009-07-01HYDROXYZINE PAMOATEORALCAPSULE005550324ANDA088488b1836032-29b4-43ae-a110-14ac2f9f1d3e

hydroxyzine pamoate 25 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000695410VistarilNDAPfizer Labs1994-11-28HYDROXYZINE PAMOATEORALCAPSULENDA011459c271f97f-040e-492b-9194-2c8b74675a95

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1001850613ANDAEon Labs, Inc.1981-12-142019-04-10HYDROXYZINE PAMOATEORALCAPSULEANDA087479c38cfd32-2562-4d6c-8a2e-d9984c16d9eb
2001850674ANDAEon Labs, Inc.2014-06-27HYDROXYZINE PAMOATEORALCAPSULEANDA087479c38cfd32-2562-4d6c-8a2e-d9984c16d9eb
3005550323ANDABarr Laboratories Inc.1984-07-01HYDROXYZINE PAMOATEORALCAPSULEANDA08849606068fff-2e79-4721-bcc7-b0938aa20e7a
4005910800ANDAWatson Laboratories, Inc.1996-07-15HYDROXYZINE PAMOATEORALCAPSULEANDA040156a3673d64-500b-4541-9538-c366f67ff687
5649800169ANDARising Pharmaceuticals, Inc.2010-11-17HYDROXYZINE PAMOATEORALCAPSULEANDA20150728cf4268-b8b6-4fd5-9bc6-3d44cba6cb38

relabeler product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006150331ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1981-12-14HYDROXYZINE PAMOATEORALCAPSULE001850613ANDA087479b06b74ac-4ca3-471f-9ec5-9686033f2334
2006157860ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2014-06-27HYDROXYZINE PAMOATEORALCAPSULE001850674ANDA087479bc0546bd-02cb-4d2f-b8ae-85f794561ca6
3105440556ANDABlenheim Pharmacal, Inc.2013-11-11HYDROXYZINE PAMOATEORALCAPSULE005910800ANDA04015611aab8b5-dcc8-0d4a-e054-00144ff88e88
4165900357ANDAStat Rx Usa Llc1981-12-14HYDROXYZINE PAMOATEORALCAPSULE001850613ANDA087479b6a5fb1e-b133-452d-ba97-84c1cca03fc1
5216950573ANDARebel Distributors Corp1996-07-15HYDROXYZINE PAMOATEORALCAPSULE005910800ANDA04015692b5435b-eab1-4e4e-a689-18dbc84b9984
6242360133ANDARemedyrepack Inc.2013-04-08HYDROXYZINE PAMOATEORALCAPSULE005550323ANDA088496fa29c395-2432-4c5a-b85b-eb1962949a5e
7242360341ANDARemedyrepack Inc.2013-06-24, 2013-08-21HYDROXYZINE PAMOATEORALCAPSULE001850613ANDA08747958e9eae5-d6ce-423f-bdb9-40b16c13733c, be5c4f3d-3940-4a87-be8a-803dff5fcbe8
8353560938ANDALake Erie Medical Dba Quality Care Products Llc1984-07-01HYDROXYZINE PAMOATEORALCAPSULE005550323ANDA088496e3608ed5-b813-4d11-9687-3ff833d643f6
9422910322ANDAAvkare, Inc.2013-03-07HYDROXYZINE PAMOATEORALCAPSULE005910800ANDA040156f1098410-0ae9-108f-957d-96908dfda483
10425490528ANDAStat Rx Usa Llc1996-07-15HYDROXYZINE PAMOATEORALCAPSULE005910800ANDA040156b23963af-653f-43cb-bb42-e09df8c06998
11430630406ANDAPd-Rx Pharmaceuticals, Inc.1981-12-14HYDROXYZINE PAMOATEORALCAPSULE001850613ANDA08747998a1c161-5728-4626-a6b0-5414935e4eef
12433530199ANDAAphena Pharma Solutions - Tennessee, Llc1996-07-15HYDROXYZINE PAMOATEORALCAPSULE005910800ANDA040156846afd7f-f838-4ca0-88a4-fc108530c711
13493490441ANDARemedyrepack Inc.2011-08-03, 2011-11-16HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE PAMOATEORALCAPSULE005910800ANDA040156242260fb-163a-4903-843d-acc478baca0c, 39010d6a-11de-4f00-880d-a687aa80db6f
14499990701ANDALake Erie Medical Dba Quality Care Products Llc1996-07-15HYDROXYZINE PAMOATEORALCAPSULE005910800ANDA0401568d5805fb-d8a0-4197-8341-26f438b08b8a
15510790077ANDAMylan Institutional Inc.2007-11-26HYDROXYZINE PAMOATEORALCAPSULE005550323ANDA088496ffff4bb7-30c3-4880-8fcc-a1a2a09ce16d
16529590433ANDAH.J. Harkins Company, Inc.2010-07-01HYDROXYZINE PAMOATEORALCAPSULE005550323ANDA088496b0919f40-ed4f-47ce-98bc-9898b4a84862
17538080373ANDAState Of Florida Doh Central Pharmacy2009-07-01HYDROXYZINE PAMOATEORALCAPSULE005550323ANDA088496b1836032-29b4-43ae-a110-14ac2f9f1d3e
18538080426ANDAState Of Florida Doh Central Pharmacy2009-07-01HYDROXYZINE PAMOATEORALCAPSULE005910800ANDA040156af6f0641-7030-4d25-aca2-bd50c3827643
19538080886ANDAState Of Florida Doh Central Pharmacy2014-01-01HYDROXYZINE PAMOATEORALCAPSULE649800169ANDA201507cc4651a4-7460-4fa8-8d21-26e1968682f6
20545692353ANDAA-S Medication Solutions Llc1981-12-14HYDROXYZINE PAMOATEORALCAPSULE001850613ANDA08747913fc12dd-f638-42ce-b85c-36d88cc2219e
21548682892ANDAPhysicians Total Care, Inc.2000-02-09HYDROXYZINE PAMOATEORALCAPSULE001850613ANDA087479ba04ac99-6321-4431-97e1-e18083d7b137
22551544975ANDACardinal Health2013-06-12HYDROXYZINE PAMOATEORALCAPSULE625840739ANDA0874790a576f6c-fd85-4934-886c-be0d4a345e39
23551545564ANDACardinal Health2012-09-25HYDROXYZINE PAMOATEORALCAPSULE510790077ANDA08849659b53047-03a1-4ed2-aa6b-fff75796c65c
24552890226ANDAPd-Rx Pharmaceuticals, Inc.1996-07-15HYDROXYZINE PAMOATEORALCAPSULE005910800ANDA040156c1b478ba-9e46-48fd-b76d-7f9a74f18d95
25581180025ANDAClinical Solutions Wholesale1981-12-14HYDROXYZINE PAMOATEORALCAPSULE001850674ANDA087479e3db41a6-b00e-4406-9e91-d840dd23c93c
26581180613ANDAClinical Solutions Wholesale1981-12-14HYDROXYZINE PAMOATEORALCAPSULE001850613ANDA087479e3db41a6-b00e-4406-9e91-d840dd23c93c
27604290294ANDAGolden State Medical Supply, Inc.2014-05-20HYDROXYZINE PAMOATEORALCAPSULE649800169ANDA2015078d4040f1-9ddb-448d-8aaa-b3961d7d2f1b
28617860148ANDARemedyrepack Inc.2015-03-09, 2015-05-18HYDROXYZINE PAMOATEORALCAPSULE001850674ANDA0874794cccb3f0-1cda-4dcb-95bb-d4a04b064b6c, ae9964e3-03e5-4c61-9ac3-76577bb8bb62
29617860201ANDARemedyrepack Inc.2015-03-09HYDROXYZINE PAMOATEORALCAPSULE001850674ANDA087479d0400209-c949-454e-9c7f-8006b392d778
30619190357ANDADirect Rx2014-01-01HYDROXYZINE PAMOATEORALCAPSULE005550323ANDA0884964290519c-dc08-40d6-94d0-1f663bb8d656
31625840739ANDAAmerican Health Packaging2013-06-122015-11-30HYDROXYZINE PAMOATEORALCAPSULE001850613ANDA087479b08d882e-a1c9-404c-ab7f-32165e68167f
32631870034ANDAProficient Rx Lp1996-07-15HYDROXYZINE PAMOATEORALCAPSULE005910800ANDA040156664d2b50-b88d-4727-ba57-a05dfcff0fce
33636291533ANDABryant Ranch Prepack1996-07-15HYDROXYZINE PAMOATEORALCAPSULE005910800ANDA040156aba7d887-5921-e9d8-0f40-c7f7a80d1d4b
34647250169ANDATya Pharmaceuticals2010-11-17HYDROXYZINE PAMOATEORALCAPSULE649800169ANDA20150729130fb6-7920-4cea-af10-7d23029a7140
35647250323ANDATya Pharmaceuticals1984-07-01HYDROXYZINE PAMOATEORALCAPSULE005550323ANDA0884961094b1ca-bb30-435c-8b2a-27d9fc79f119
36647250800ANDATya Pharmaceuticals1996-07-15HYDROXYZINE PAMOATEORALCAPSULE005910800ANDA04015617c106d6-386a-4d27-859a-a8f96a5cdb54
37670460281ANDAContract Pharmacy Services-Pa2010-08-16HYDROXYZINE PAMOATEORALCAPSULE001850613ANDA0874792bbcabc3-657f-4b2e-a473-774adfeba78e
38672960152ANDARedpharm Drug Inc.2010-07-01HYDROXYZINE PAMOATEORALCAPSULE005550323ANDA088496740fad03-94a7-4da6-86e2-a1622d907f27
39680840847ANDAAmerican Health Packaging2015-02-15HYDROXYZINE PAMOATEORALCAPSULE001850674ANDA0874791988fa7f-282f-438c-8429-570a0f59c801
40687889129ANDAPreferred Pharmaceuticals, Inc.2004-07-212019-04-10HYDROXYZINE PAMOATEORALCAPSULE001850613ANDA087479fe8d07a0-979f-4859-8f43-1be2a54dcc1a
41687889386ANDAPreferred Pharmaceuticals, Inc.2014-07-23HYDROXYZINE PAMOATEORALCAPSULE649800169ANDA201507ec7783c9-302f-4904-8046-b5ed43bb94b8
42687889696ANDAPreferred Pharmaceuticals, Inc.2013-04-22HYDROXYZINE PAMOATEORALCAPSULE005550323ANDA0884960459b583-ef1c-4b82-8467-f4b80e9e2a46

hydroxyzine pamoate 50 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000695420VistarilNDAPfizer Labs1968-11-15HYDROXYZINE PAMOATEORALCAPSULENDA011459c271f97f-040e-492b-9194-2c8b74675a95

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850615ANDAEon Labs, Inc.1981-12-14HYDROXYZINE PAMOATEORALCAPSULEANDA086183c38cfd32-2562-4d6c-8a2e-d9984c16d9eb
2005550302ANDABarr Laboratories Inc.1984-07-01HYDROXYZINE PAMOATEORALCAPSULEANDA08848706068fff-2e79-4721-bcc7-b0938aa20e7a
3005910801ANDAWatson Laboratories, Inc.1996-06-15HYDROXYZINE PAMOATEORALCAPSULEANDA040156a3673d64-500b-4541-9538-c366f67ff687
4649800170ANDARising Pharmaceuticals, Inc.2010-11-17HYDROXYZINE PAMOATEORALCAPSULEANDA20150728cf4268-b8b6-4fd5-9bc6-3d44cba6cb38

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006150332ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1981-12-14HYDROXYZINE PAMOATEORALCAPSULE001850615ANDA0861835cff9ae0-9e7d-4920-96a7-acad6c30a5b9
2165900737ANDAStat Rx Usa Llc1996-06-15HYDROXYZINE PAMOATEORALCAPSULE005910801ANDA040156be1723df-6677-4670-89f7-721578897380
3242360070ANDARemedyrepack Inc.2013-03-19, 2013-04-09HYDROXYZINE PAMOATEORALCAPSULE005910801ANDA04015622a65162-a8b5-4f5f-9d00-50af7fccb54f, 37ba759d-f379-4f26-b50f-eb797f4b0196
4332610858ANDAAidarex Pharmaceuticals Llc1981-12-14HYDROXYZINE PAMOATEORALCAPSULE001850615ANDA086183f305fb4a-f78f-49ff-b679-ebe84649f5a6
5422910323ANDAAvkare, Inc.2013-03-07HYDROXYZINE PAMOATEORALCAPSULE005910801ANDA040156f1098410-0ae9-108f-957d-96908dfda483
6424950170ANDAWestwood Manufacturing2010-11-17HYDROXYZINE PAMOATEORALCAPSULE649800170ANDA201507e97b2b86-bea0-4203-97c8-b27510a524a3
7493490480ANDARemedyrepack Inc.2011-08-12, 2013-07-26HYDROXYZINE HYDROCHLORIDEORALCAPSULE005910801ANDA040156349d7f8e-5076-4998-bb67-e8e5f5cd17be, a6489a49-be1b-4e33-beba-986e58249afb, b6ee6501-d90b-4a2c-af4e-073e567e2a5b
8510790078ANDAMylan Institutional Inc.2007-11-26HYDROXYZINE PAMOATEORALCAPSULE005550302ANDA088487ffff4bb7-30c3-4880-8fcc-a1a2a09ce16d
9521250001VistarilNDARemedyrepack Inc.2013-03-11HYDROXYZINE PAMOATEORALCAPSULE000695420NDA01145917f166b4-5202-4b7c-bbb6-7922c36ab2ca
10538080374ANDAState Of Florida Doh Central Pharmacy2009-07-01HYDROXYZINE PAMOATEORALCAPSULE005550302ANDA088487b1836032-29b4-43ae-a110-14ac2f9f1d3e
11538080429ANDAState Of Florida Doh Central Pharmacy2009-07-01HYDROXYZINE PAMOATEORALCAPSULE005910801ANDA040156af6f0641-7030-4d25-aca2-bd50c3827643
12545692571ANDAA-S Medication Solutions Llc1981-12-14HYDROXYZINE PAMOATEORALCAPSULE001850615ANDA08618313fc12dd-f638-42ce-b85c-36d88cc2219e
13548681854ANDAPhysicians Total Care, Inc.1996-05-142012-06-30HYDROXYZINE PAMOATEORALCAPSULE001850615ANDA086183ba04ac99-6321-4431-97e1-e18083d7b137
14551545092ANDACardinal Health2011-08-03HYDROXYZINE PAMOATEORALCAPSULE510790078ANDA08848759b53047-03a1-4ed2-aa6b-fff75796c65c
15552890354ANDAPd-Rx Pharmaceuticals, Inc.1981-12-14HYDROXYZINE PAMOATEORALCAPSULE001850615ANDA086183d49da9c1-c2be-4e6d-9fd0-5abea49e1ef1
16581180615ANDAClinical Solutions Wholesale1981-12-14HYDROXYZINE PAMOATEORALCAPSULE001850615ANDA086183e3db41a6-b00e-4406-9e91-d840dd23c93c
17604290295ANDAGolden State Medical Supply, Inc.2014-05-20HYDROXYZINE PAMOATEORALCAPSULE649800170ANDA2015078d4040f1-9ddb-448d-8aaa-b3961d7d2f1b
18617860446ANDARemedyrepack Inc.2015-10-20HYDROXYZINE PAMOATEORALCAPSULE001850615ANDA08618373e05e27-2db4-4282-9f05-dac752dbcfa7
19625840741ANDAAmerican Health Packaging2013-06-12HYDROXYZINE PAMOATEORALCAPSULE001850615ANDA086183b08d882e-a1c9-404c-ab7f-32165e68167f
20636295415ANDABryant Ranch Prepack1996-07-15HYDROXYZINE PAMOATEORALCAPSULE005910800ANDA04015670d6bffc-868c-47ce-b0b8-e16feb3bcdc0
21647250170ANDATya Pharmaceuticals2010-11-17HYDROXYZINE PAMOATEORALCAPSULE649800170ANDA20150729130fb6-7920-4cea-af10-7d23029a7140
22647250302ANDATya Pharmaceuticals1984-07-01HYDROXYZINE PAMOATEORALCAPSULE005550302ANDA0884871094b1ca-bb30-435c-8b2a-27d9fc79f119
23647250801ANDATya Pharmaceuticals1996-06-15HYDROXYZINE PAMOATEORALCAPSULE005910801ANDA04015617c106d6-386a-4d27-859a-a8f96a5cdb54
24670460282ANDAContract Pharmacy Services-Pa2010-08-16HYDROXYZINE PAMOATEORALCAPSULE001850615ANDA0861832bbcabc3-657f-4b2e-a473-774adfeba78e
25687880523ANDAPreferred Pharmaceuticals, Inc.2004-07-21HYDROXYZINE PAMOATEORALCAPSULE001850615ANDA086183fe8d07a0-979f-4859-8f43-1be2a54dcc1a
26691890615ANDAAvera Mckennan Hospital2015-03-01HYDROXYZINE PAMOATEORALCAPSULE001850615ANDA086183328ffc0a-491d-4f03-8f49-59c0df2961ba

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040156HYDROXYZINE PAMOATEWATSON LABORATORIES INC1996-07-15ANDA040156_001, ANDA040156_002
2ANDA081127HYDROXYZINE PAMOATETrueSANDOZ INC1991-06-28ANDA081127_001
3ANDA081128HYDROXYZINE PAMOATETrueSANDOZ INC1991-06-28ANDA081128_001
4ANDA081129HYDROXYZINE PAMOATETrueSANDOZ INC1991-06-28ANDA081129_001
5ANDA081165HYDROXYZINE PAMOATETrueWATSON LABORATORIES INC1991-07-31ANDA081165_001
6ANDA086183HYDROXYZINE PAMOATESANDOZ INCANDA086183_001
7ANDA086695HYDROXYZINE PAMOATETrueWATSON LABORATORIES INCANDA086695_001
8ANDA086697HYDROXYZINE PAMOATETrueWATSON LABORATORIES INCANDA086697_001
9ANDA086698HYDROXYZINE PAMOATETrueWATSON LABORATORIES INCANDA086698_001
10ANDA086705HYDROXYZINE PAMOATETrueWATSON LABORATORIES INC1982-07-01ANDA086705_001
11ANDA086728HYDROXYZINE PAMOATETrueWATSON LABORATORIES INC1982-10-05ANDA086728_001
12ANDA086840HYDROXYZINE PAMOATETrueWATSON LABORATORIES INC1982-07-01ANDA086840_001
13ANDA087479HYDROXYZINE PAMOATESANDOZ INCANDA087479_001
14ANDA087656HYDROXYZINE PAMOATETruePAR PHARMACEUTICAL INC1982-06-11ANDA087656_001
15ANDA087657HYDROXYZINE PAMOATETruePAR PHARMACEUTICAL INC1982-06-11ANDA087657_001
16ANDA087658HYDROXYZINE PAMOATETruePAR PHARMACEUTICAL INC1982-06-11ANDA087658_001
17ANDA087760HYDROXYZINE PAMOATETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1982-03-05ANDA087760_001
18ANDA087761HYDROXYZINE PAMOATETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1982-03-05ANDA087761_001
19ANDA087767HYDROXYZINE PAMOATETrueWATSON LABORATORIES INC1982-08-16ANDA087767_001
20ANDA087790HYDROXYZINE PAMOATETrueWATSON LABORATORIES INC1982-08-16ANDA087790_001
21ANDA088392HYDROXYZINE PAMOATETrueVANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO1983-09-19ANDA088392_001
22ANDA088393HYDROXYZINE PAMOATETrueVANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO1983-09-19ANDA088393_001
23ANDA088487HYDROXYZINE PAMOATEBARR LABORATORIES INC1984-06-15ANDA088487_001
24ANDA088488HYDROXYZINE PAMOATEBARR LABORATORIES INC1984-06-15ANDA088488_001
25ANDA088496HYDROXYZINE PAMOATEBARR LABORATORIES INC1984-06-15ANDA088496_001
26ANDA088593HYDROXYZINE PAMOATETrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1984-02-29ANDA088593_001
27ANDA088594HYDROXYZINE PAMOATETrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1984-02-29ANDA088594_001
28ANDA088595HYDROXYZINE PAMOATETrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1984-02-29ANDA088595_001
29ANDA088713HY-PAM \"25\"TrueTEVA PHARMACEUTICALS USA INC1985-03-04ANDA088713_001
30ANDA089031HYDROXYZINE PAMOATETrueSUPERPHARM CORP1987-01-02ANDA089031_001
31ANDA089032HYDROXYZINE PAMOATETrueSUPERPHARM CORP1987-01-02ANDA089032_001
32ANDA089033HYDROXYZINE PAMOATETrueSUPERPHARM CORP1987-01-02ANDA089033_001
33ANDA089145HYDROXYZINE PAMOATETruePAR PHARMACEUTICAL INC1986-03-17ANDA089145_001
34ANDA089146HYDROXYZINE PAMOATETruePAR PHARMACEUTICAL INC1986-03-17ANDA089146_001
35ANDA201507HYDROXYZINE PAMOATEHERITAGE PHARMA LABS INC2013-06-03ANDA201507_001, ANDA201507_002
36NDA011459VISTARILPFIZER LABORATORIES DIV PFIZER INCNDA011459_002, NDA011459_004, NDA011459_006

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040156_001RXHYDROXYZINE PAMOATE (EQ 25MG HCL)ORALCAPSULEFalseAB1996-07-15HYDROXYZINE PAMOATE
2ANDA040156_002RXHYDROXYZINE PAMOATE (EQ 50MG HCL)ORALCAPSULEFalseAB1996-07-15HYDROXYZINE PAMOATE
3ANDA081127_001discontinuedHYDROXYZINE PAMOATE (EQ 25MG HCL)ORALCAPSULEFalse1991-06-28HYDROXYZINE PAMOATE
4ANDA081128_001discontinuedHYDROXYZINE PAMOATE (EQ 50MG HCL)ORALCAPSULEFalse1991-06-28HYDROXYZINE PAMOATE
5ANDA081129_001discontinuedHYDROXYZINE PAMOATE (EQ 100MG HCL)ORALCAPSULEFalse1991-06-28HYDROXYZINE PAMOATE
6ANDA081165_001discontinuedHYDROXYZINE PAMOATE (EQ 25MG HYDROCHLORIDE)ORALCAPSULEFalse1991-07-31HYDROXYZINE PAMOATE
7ANDA086183_001RXHYDROXYZINE PAMOATE (EQ 50MG HCL)ORALCAPSULEFalseABHYDROXYZINE PAMOATE
8ANDA086695_001discontinuedHYDROXYZINE PAMOATE (EQ 50MG HCL)ORALCAPSULEFalseHYDROXYZINE PAMOATE
9ANDA086697_001discontinuedHYDROXYZINE PAMOATE (EQ 100MG HCL)ORALCAPSULEFalseHYDROXYZINE PAMOATE
10ANDA086698_001discontinuedHYDROXYZINE PAMOATE (EQ 25MG HCL)ORALCAPSULEFalseHYDROXYZINE PAMOATE
11ANDA086705_001discontinuedHYDROXYZINE PAMOATE (EQ 50MG HCL)ORALCAPSULEFalse1982-07-01HYDROXYZINE PAMOATE
12ANDA086728_001discontinuedHYDROXYZINE PAMOATE (EQ 100MG HCL)ORALCAPSULEFalse1982-10-05HYDROXYZINE PAMOATE
13ANDA086840_001discontinuedHYDROXYZINE PAMOATE (EQ 25MG HCL)ORALCAPSULEFalse1982-07-01HYDROXYZINE PAMOATE
14ANDA087479_001RXHYDROXYZINE PAMOATE (EQ 25MG HCL)ORALCAPSULEFalseABHYDROXYZINE PAMOATE
15ANDA087656_001discontinuedHYDROXYZINE PAMOATE (EQ 25MG HCL)ORALCAPSULEFalse1982-06-11HYDROXYZINE PAMOATE
16ANDA087657_001discontinuedHYDROXYZINE PAMOATE (EQ 50MG HCL)ORALCAPSULEFalse1982-06-11HYDROXYZINE PAMOATE
17ANDA087658_001discontinuedHYDROXYZINE PAMOATE (EQ 100MG HCL)ORALCAPSULEFalse1982-06-11HYDROXYZINE PAMOATE
18ANDA087760_001discontinuedHYDROXYZINE PAMOATE (EQ 50MG HCL)ORALCAPSULEFalse1982-03-05HYDROXYZINE PAMOATE
19ANDA087761_001discontinuedHYDROXYZINE PAMOATE (EQ 25MG HCL)ORALCAPSULEFalse1982-03-05HYDROXYZINE PAMOATE
20ANDA087767_001discontinuedHYDROXYZINE PAMOATE (EQ 50MG HCL)ORALCAPSULEFalse1982-08-16HYDROXYZINE PAMOATE
21ANDA087790_001discontinuedHYDROXYZINE PAMOATE (EQ 100MG HCL)ORALCAPSULEFalse1982-08-16HYDROXYZINE PAMOATE
22ANDA088392_001discontinuedHYDROXYZINE PAMOATE (EQ 25MG HCL)ORALCAPSULEFalse1983-09-19HYDROXYZINE PAMOATE
23ANDA088393_001discontinuedHYDROXYZINE PAMOATE (EQ 50MG HCL)ORALCAPSULEFalse1983-09-19HYDROXYZINE PAMOATE
24ANDA088487_001RXHYDROXYZINE PAMOATE (EQ 50MG HCL)ORALCAPSULEFalseAB1984-06-15HYDROXYZINE PAMOATE
25ANDA088488_001RXHYDROXYZINE PAMOATE (EQ 100MG HCL)ORALCAPSULEFalse1984-06-15HYDROXYZINE PAMOATE
26ANDA088496_001RXHYDROXYZINE PAMOATE (EQ 25MG HCL)ORALCAPSULEFalseAB1984-06-15HYDROXYZINE PAMOATE
27ANDA088593_001discontinuedHYDROXYZINE PAMOATE (EQ 25MG HCL)ORALCAPSULEFalse1984-02-29HYDROXYZINE PAMOATE
28ANDA088594_001discontinuedHYDROXYZINE PAMOATE (EQ 50MG HCL)ORALCAPSULEFalse1984-02-29HYDROXYZINE PAMOATE
29ANDA088595_001discontinuedHYDROXYZINE PAMOATE (EQ 100MG HCL)ORALCAPSULEFalse1984-02-29HYDROXYZINE PAMOATE
30ANDA088713_001discontinuedHYDROXYZINE PAMOATE (EQ 25MG HCL)ORALCAPSULEFalse1985-03-04HY-PAM \"25\"
31ANDA089031_001discontinuedHYDROXYZINE PAMOATE (EQ 25MG HCL)ORALCAPSULEFalse1987-01-02HYDROXYZINE PAMOATE
32ANDA089032_001discontinuedHYDROXYZINE PAMOATE (EQ 50MG HCL)ORALCAPSULEFalse1987-01-02HYDROXYZINE PAMOATE
33ANDA089033_001discontinuedHYDROXYZINE PAMOATE (EQ 100MG HCL)ORALCAPSULEFalse1987-01-02HYDROXYZINE PAMOATE
34ANDA089145_001discontinuedHYDROXYZINE PAMOATE (EQ 25MG HCL)ORALCAPSULEFalse1986-03-17HYDROXYZINE PAMOATE
35ANDA089146_001discontinuedHYDROXYZINE PAMOATE (EQ 50MG HCL)ORALCAPSULEFalse1986-03-17HYDROXYZINE PAMOATE
36ANDA201507_001RXHYDROXYZINE PAMOATE (EQ 25MG HYDROCHLORIDE)ORALCAPSULEFalseAB2013-06-03HYDROXYZINE PAMOATE
37ANDA201507_002RXHYDROXYZINE PAMOATE (EQ 50MG HYDROCHLORIDE)ORALCAPSULEFalseAB2013-06-03HYDROXYZINE PAMOATE
38NDA011459_002RXHYDROXYZINE PAMOATE (EQ 25MG HCL)ORALCAPSULEFalseABVISTARIL
39NDA011459_004RXHYDROXYZINE PAMOATE (EQ 50MG HCL)ORALCAPSULETrueABVISTARIL
40NDA011459_006discontinuedHYDROXYZINE PAMOATE (EQ 100MG HCL)ORALCAPSULEFalseVISTARIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10459b583-ef1c-4b82-8467-f4b80e9e2a46 (view SPL)HYDROXYZINE PAMOATE CAPSULES USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-01-135687889696
206068fff-2e79-4721-bcc7-b0938aa20e7a (view SPL)HYDROXYZINE PAMOATE CAPSULES USPprescriptionHuman PrescriptionBarr Laboratories Inc.2014-08-069005550302, 005550323, 005550324
30a576f6c-fd85-4934-886c-be0d4a345e39 (view SPL)Hydroxyzine Pamoate Capsules USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-08-052551544975
41094b1ca-bb30-435c-8b2a-27d9fc79f119 (view SPL)HYDROXYZINE PAMOATE CAPSULES USPprescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2014-08-064647250302, 647250323
511aab8b5-dcc8-0d4a-e054-00144ff88e88 (view SPL)HydrOXYzine Pamoate Capsules USP Rx onlyprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-03-191105440556
613fc12dd-f638-42ce-b85c-36d88cc2219e (view SPL)Hydroxyzine Pamoate Capsules USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-10-061545692353, 545692571
717c106d6-386a-4d27-859a-a8f96a5cdb54 (view SPL)HydrOXYzine Pamoate Capsules USP Rx onlyprescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2012-10-184647250800, 647250801
817f166b4-5202-4b7c-bbb6-7922c36ab2ca (view SPL)VISTARIL (hydroxyzine pamoate) Capsules and Oral SuspensionprescriptionHuman PrescriptionRemedyrepack Inc.2013-03-111521250001
91988fa7f-282f-438c-8429-570a0f59c801 (view SPL)HydrOXYzine Pamoate Capsules USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-02-181680840847
1022a65162-a8b5-4f5f-9d00-50af7fccb54f (view SPL)HydrOXYzine Pamoate Capsules USPRx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-03-191242360070
11242260fb-163a-4903-843d-acc478baca0c (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-11-166493490441
1228cf4268-b8b6-4fd5-9bc6-3d44cba6cb38 (view SPL)Rx onlyprescriptionHuman PrescriptionRising Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE2014-08-2110649800169, 649800170
1329130fb6-7920-4cea-af10-7d23029a7140 (view SPL)Rx onlyprescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2014-08-214647250169, 647250170
142bbcabc3-657f-4b2e-a473-774adfeba78e (view SPL)HydrOXYzine Pamoate Capsules, USP Rx onlyprescriptionHuman PrescriptionContract Pharmacy Services-Pa2010-08-171670460281, 670460282
15328ffc0a-491d-4f03-8f49-59c0df2961ba (view SPL)HydrOXYzine Pamoate Capsules USPprescriptionHuman PrescriptionAvera Mckennan Hospitalrelabel, repack2015-11-061691890615
16349d7f8e-5076-4998-bb67-e8e5f5cd17be (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-08-122493490480
1737ba759d-f379-4f26-b50f-eb797f4b0196 (view SPL)HydrOXYzine Pamoate Capsules USPRx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-04-091242360070
1839010d6a-11de-4f00-880d-a687aa80db6f (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-08-032493490441
194290519c-dc08-40d6-94d0-1f663bb8d656 (view SPL)HYDROXYZINE PAMOATEprescriptionHuman PrescriptionDirect Rxrelabel, repack2014-04-021619190357
204cccb3f0-1cda-4dcb-95bb-d4a04b064b6c (view SPL)HydrOXYzinePamoate Capsules USPprescriptionHuman PrescriptionRemedyrepack Inc.2015-05-181617860148
2158e9eae5-d6ce-423f-bdb9-40b16c13733c (view SPL)Hydroxyzine Pamoate Capsules USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-242242360341
2259b53047-03a1-4ed2-aa6b-fff75796c65c (view SPL)HYDROXYZINE PAMOATE CAPSULES USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-10-015551545092, 551545564
235cff9ae0-9e7d-4920-96a7-acad6c30a5b9 (view SPL)Rx OnlyprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsREPACK2014-05-272006150332
24664d2b50-b88d-4727-ba57-a05dfcff0fce (view SPL)HydrOXYzine Pamoate Capsules USP Rx onlyprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-04-301631870034
2570d6bffc-868c-47ce-b0b8-e16feb3bcdc0 (view SPL)HydrOXYzine Pamoate Capsules USPRx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2015-03-301002636295415
2673e05e27-2db4-4282-9f05-dac752dbcfa7 (view SPL)HydrOXYzinePamoate Capsules USPprescriptionHuman PrescriptionRemedyrepack Inc.2015-10-201617860446
27740fad03-94a7-4da6-86e2-a1622d907f27 (view SPL)HYDROXYZINE PAMOATE Capsules USPprescriptionHuman PrescriptionRedpharm Drug Inc.manufacture2011-07-155672960152
2879c93c3a-167b-4394-841f-ee491b8815a2 (view SPL)HYDROXYZINE PAMOATE CAPSULES USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-09-015430630251
29846afd7f-f838-4ca0-88a4-fc108530c711 (view SPL)HydrOXYzine Pamoate Capsules USPRx onlyprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-05-082433530199
308d4040f1-9ddb-448d-8aaa-b3961d7d2f1b (view SPL)Hydroxyzine Pamoate Capsules Rx onlyprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2014-01-011604290294, 604290295
318d5805fb-d8a0-4197-8341-26f438b08b8a (view SPL)70010463 HydrOXYzine Pamoate Capsules, USP Rx onlyprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-06-283821499990701
3292b5435b-eab1-4e4e-a689-18dbc84b9984 (view SPL)70010463 HydrOXYzine Pamoate Capsules, USP Rx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-291216950573
3398a1c161-5728-4626-a6b0-5414935e4eef (view SPL)Hydroxyzine Pamoate Capsules USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-09-2417430630406
34a3673d64-500b-4541-9538-c366f67ff687 (view SPL)HydrOXYzine Pamoate Capsules USPRx onlyprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-10-187005910800, 005910801
35a6489a49-be1b-4e33-beba-986e58249afb (view SPL)HydrOXYzine Pamoate Capsules USPRx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-07-264493490480
36aba7d887-5921-e9d8-0f40-c7f7a80d1d4b (view SPL)HydrOXYzine Pamoate Capsules, USP Rx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK1996-07-152636291533
37ae9964e3-03e5-4c61-9ac3-76577bb8bb62 (view SPL)HydrOXYzinePamoate Capsules USPprescriptionHuman PrescriptionRemedyrepack Inc.2015-03-091617860148
38af6f0641-7030-4d25-aca2-bd50c3827643 (view SPL)HydrOXYzine Pamoate Capsules, USP Rx onlyprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-05-251538080426, 538080429
39b06b74ac-4ca3-471f-9ec5-9686033f2334 (view SPL)Hydroxyzine Pamoate Capsules USP 25 mgprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsREPACK2014-05-2710006150331
40b08d882e-a1c9-404c-ab7f-32165e68167f (view SPL)HydrOXYzine Pamoate Capsules USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-02-185625840739, 625840741
41b0919f40-ed4f-47ce-98bc-9898b4a84862 (view SPL)HYDROXYZINE PAMOATE Capsules USPprescriptionHuman PrescriptionH.J. Harkins Company, Inc.relabel, repack2012-04-193529590433
42b1836032-29b4-43ae-a110-14ac2f9f1d3e (view SPL)HYDROXYZINE PAMOATE CAPSULES, USPprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-05-251538080373, 538080374, 538080431
43b23963af-653f-43cb-bb42-e09df8c06998 (view SPL)HydrOXYzine Pamoate Capsules USP 25 mgprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-04-171425490528
44b6a5fb1e-b133-452d-ba97-84c1cca03fc1 (view SPL)Hydroxyzine Pamoate Capsules USPprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-10-031165900357
45b6ee6501-d90b-4a2c-af4e-073e567e2a5b (view SPL)HydrOXYzine Pamoate Capsules USPRx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-07-2622493490480
46ba04ac99-6321-4431-97e1-e18083d7b137 (view SPL)Hydroxyzine Pamoate Capsules USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2013-02-253548681854, 548682892
47bc0546bd-02cb-4d2f-b8ae-85f794561ca6 (view SPL)HydrOXYzine Pamoate Capsules USP, 25 mg and 50 mg Rx onlyprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2014-11-121006157860
48be1723df-6677-4670-89f7-721578897380 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-06-061165900737
49be5c4f3d-3940-4a87-be8a-803dff5fcbe8 (view SPL)Hydroxyzine Pamoate Capsules USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-08-212242360341
50c1b478ba-9e46-48fd-b76d-7f9a74f18d95 (view SPL)70010463 HydrOXYzine Pamoate Capsules, USP Rx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-03-233552890226
51c271f97f-040e-492b-9194-2c8b74675a95 (view SPL)VISTARIL (hydroxyzine pamoate) Capsules and Oral SuspensionprescriptionHuman PrescriptionPfizer LabsANALYSIS, MANUFACTURE, PACK2014-05-058000695410, 000695420, 000695430, 000695440
52c38cfd32-2562-4d6c-8a2e-d9984c16d9eb (view SPL)HydrOXYzine Pamoate Capsules USPprescriptionHuman PrescriptionEon Labs, Inc.2014-08-2620001850613, 001850615, 001850674
53cc4651a4-7460-4fa8-8d21-26e1968682f6 (view SPL)Rx onlyprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2014-10-183538080886
54d0400209-c949-454e-9c7f-8006b392d778 (view SPL)HydrOXYzinePamoate Capsules USPprescriptionHuman PrescriptionRemedyrepack Inc.2015-03-092617860201
55d49da9c1-c2be-4e6d-9fd0-5abea49e1ef1 (view SPL)Hydroxyzine Pamoate Capsules USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-09-2313552890354
56e3608ed5-b813-4d11-9687-3ff833d643f6 (view SPL)HYDROXYZINE PAMOATE CAPSULES USPprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-08-281353560938
57e3db41a6-b00e-4406-9e91-d840dd23c93c (view SPL)Hydroxyzine Pamoate Capsules USPprescriptionHuman PrescriptionClinical Solutions Wholesalerepack2015-09-152581180025, 581180613, 581180615
58e97b2b86-bea0-4203-97c8-b27510a524a3 (view SPL)Rx onlyprescriptionHuman PrescriptionWestwood Manufacturingrepack2014-08-252424950170
59ec7783c9-302f-4904-8046-b5ed43bb94b8 (view SPL)Rx onlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-01-133687889386
60f1098410-0ae9-108f-957d-96908dfda483 (view SPL)HydrOXYzine Pamoate Capsules USPRx onlyprescriptionHuman PrescriptionAvkare, Inc.2013-03-071422910322, 422910323
61f305fb4a-f78f-49ff-b679-ebe84649f5a6 (view SPL)Hydroxyzine Pamoate Capsules USPprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-041332610858
62fa29c395-2432-4c5a-b85b-eb1962949a5e (view SPL)HYDROXYZINE PAMOATE CAPSULES USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-04-081242360133
63fe8d07a0-979f-4859-8f43-1be2a54dcc1a (view SPL)HydrOXYzinePamoate Capsules USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-01-137687880523, 687889129
64ffff4bb7-30c3-4880-8fcc-a1a2a09ce16d (view SPL)HYDROXYZINE PAMOATE CAPSULES USPprescriptionHuman PrescriptionMylan Institutional Inc.2015-02-064510790077, 510790078

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII