Loperamide Oral Suspension

Brand(s)
Imodium
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division (2015-11-06)
Oldest Current Product
2005-01-01
License(s)
NDA, ANDA
RxNORM
ORAL SUSPENSION\LOPERAMIDE
FDAOB
ORAL\SOLUTION\LOPERAMIDE HYDROCHLORIDE
ORAL\SUSPENSION\LOPERAMIDE HYDROCHLORIDE
SPL Active
ORAL\LIQUID\LOPERAMIDE HYDROCHLORIDE
ORAL\SOLUTION\LOPERAMIDE HYDROCHLORIDE
ORAL\SUSPENSION\LOPERAMIDE HYDROCHLORIDE
SPL Moiety
ORAL\LIQUID\LOPERAMIDE
ORAL\SOLUTION\LOPERAMIDE
ORAL\SUSPENSION\LOPERAMIDE

product(s) by strength(s)

loperamide hydrochloride 0.133 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1505800134ImodiumNDAJohnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division2005-01-01LOPERAMIDE HYDROCHLORIDEORALSOLUTIONNDA01948776a976d5-8bee-4158-a94d-7fbfc5544fd4

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001130645ANDAL. Perrigo Company2012-01-31LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA09129236605a13-e93e-4b25-a888-dc64c2130c2e
2003630645ANDAWalgreens2012-05-18LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA09129265abebcc-f5e2-4bd5-bf37-20e0fb53dc4c
3009046256ANDAMajor2012-03-14LOPERAMIDE HYDROCHLORIDEORALLIQUIDANDA0912926d67a0ed-3f4d-4462-be73-5267809c70c3
4118221645ANDARite Aid2012-05-23LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA091292efb4ab17-7a75-4e1a-9078-457af14c473a
5301420645ANDAKroger2013-08-06LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA0912921f8a3818-53b8-4749-b330-56b0f3b90a8a
6368000645ANDATop Care (Topco Associates Llc)2012-06-05LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA091292e09a277c-03b5-4d09-9058-a2d635e7d03c
7370120645ANDAShopko Stores Operating Co, Llc2013-08-08LOPERAMIDE HYDROCHLORIDEORALLIQUIDANDA091292c93d70ec-6f77-42ff-a461-b2f152011e86
8372050584ANDACardinal Health2012-03-28LOPERAMIDE HYDROCHLORIDEORALLIQUIDANDA09129285a0f267-2a12-46cb-9d85-4fb0b34b4d74
9378080645ANDAH-E-B2012-03-05LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA09129282b4ecac-7725-48e2-9cc2-ba856ed70d2e
10411630645ANDASupervalu, Inc2012-02-06LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA091292ee097be5-c4aa-4584-bf6f-5c9dc2fc615c
11412500645ANDAMeijer Distribution, Inc2012-05-11LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA09129225e2d8e7-412d-4206-b2dc-9bf4af928d45
12415200645ANDAFoodhold U.S.A., Llc2012-05-21LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA091292261d89d1-37cb-4af9-ad82-7e79f8da2e7f
13415200758ANDAFoodhold U.S.A., Llc2014-05-10LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA0912928471db91-e87a-4399-a250-276a9f174fbd
14425070645ANDAHy-Vee2012-04-30LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA091292bce1bbaf-1f2c-4a53-9c20-67f0c7dddf6b
15461220111ANDAAmerisource Bergen2012-02-17LOPERAMIDE HYDROCHLORIDEORALLIQUIDANDA091292f033c0e6-25da-4290-8e9c-2f3eafdf3f03
16461220241ANDAAmerisource Bergen2014-01-31LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA0912922e7a424d-6626-4772-bb47-bd5d3dd181b3
17490350645ANDAWalmart2011-10-07LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA091292a3eda337-1930-4179-a8c1-7f8ef20827a4
18493480999ANDASunmark2014-02-18LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA0912929f3faa14-3717-4c51-a28d-2bad40d4fc88
19497380645ANDAKmart Corp2012-05-14LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA091292950fa674-1a6b-457d-a5ba-7c9166c77f33
20497810061ANDACardinal Health, Inc.2014-04-23LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA091292cfa6b8f7-d890-44ee-b27e-c0c538042461
21497810089ANDACardinal Health, Inc.2014-05-30LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA0912926f421dda-eed1-41bd-98f2-ffa2fb41f6ec
22553120645ANDAWestern Family2012-05-19LOPERAMIDE HYDROCHLORIDEORALLIQUIDANDA091292d0f42e02-3b56-488a-a4dc-aaafa6b10259
23553120758ANDAWestern Family2014-05-21LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA091292a3a81c6e-d4da-44fa-9839-357abc3b54c2
24559100645ANDADolgencorp, Llc2012-07-26LOPERAMIDE HYDROCHLORIDEORALLIQUIDANDA09129260546513-376c-4707-b554-2f65a0d24bc1
25597790645ANDACvs2012-02-28LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA0912923fc5778f-a211-455c-878f-36fae523159c
26597790758ANDACvs2014-02-04LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA0912921c0f455a-a52e-4762-baf7-a3ac741e08f9
27617150107ANDAPreferred Plus (Kinray)2014-05-27LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA091292ae165253-41ef-463f-ab08-8f8b501264b6
28617150108ANDAPreferred Plus (Kinray)2014-06-09LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA09129295850912-0d07-46e4-88b7-57f2b800d2bd
29620110151ANDAMckesson (Health Mart)2012-03-20LOPERAMIDE HYDROCHLORIDEORALLIQUIDANDA091292af1474cf-5ce2-400f-a975-c5904048dc5b
30620110236ANDAMckesson (Health Mart)2014-06-11LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA091292629987c1-abf3-4149-afba-f306c55e44ad
31692560645ANDAHarris Teeter, Llc2015-03-30LOPERAMIDE HYDROCHLORIDEORALSUSPENSIONANDA091292a2051c7f-dab8-4adc-97ce-e823830e0dc5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1680940107ANDAPrecision Dose Inc.2014-02-26LOPERAMIDE HYDROCHLORIDEORALSUSPENSION001130645ANDA0912922845ad4d-0442-45dc-8599-da7b4c8b78f3
2680940108ANDAPrecision Dose Inc.2014-02-26LOPERAMIDE HYDROCHLORIDEORALSUSPENSION001130645ANDA09129245b3d2da-5321-4188-a011-281d1ee3cbfa
3687889704ANDAPreferred Pharmaceuticals, Inc.2013-03-08LOPERAMIDE HYDROCHLORIDEORALLIQUID009046256ANDA0912926270ee8b-fa2c-4f06-8eaf-fc81716d9921

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA073062LOPERAMIDE HYDROCHLORIDETrueWATSON LABORATORIES INC1993-05-28ANDA073062_001Loperamide Oral Solution
Lorazepam Oral Solution
2ANDA073079LOPERAMIDE HYDROCHLORIDEROXANE LABORATORIES INC1992-04-30ANDA073079_001Loperamide Oral Solution
Lorazepam Oral Solution
3ANDA073187LOPERAMIDE HYDROCHLORIDETrueALPHARMA US PHARMACEUTICALS DIVISION1992-09-15ANDA073187_001Loperamide Oral Solution
Lorazepam Oral Solution
4ANDA073243LOPERAMIDE HYDROCHLORIDEL PERRIGO CO1992-01-21ANDA073243_001Loperamide Oral Solution
Lorazepam Oral Solution
5ANDA073478LOPERAMIDE HYDROCHLORIDETrueTEVA PHARMACEUTICALS USA INC1995-06-23ANDA073478_001Loperamide Oral Solution
Lorazepam Oral Solution
6ANDA074352LOPERAMIDE HYDROCHLORIDEHI TECH PHARMACAL CO INC1995-11-17ANDA074352_001Loperamide Oral Solution
Lorazepam Oral Solution
7ANDA074730LOPERAMIDE HYDROCHLORIDEWOCKHARDT EU OPERATIONS (SWISS) AG1997-08-28ANDA074730_001Loperamide Oral Solution
Lorazepam Oral Solution
8ANDA074991LOPERAMIDE HYDROCHLORIDETrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1997-12-29ANDA074991_001Loperamide Oral Solution
Lorazepam Oral Solution
9ANDA091292LOPERAMIDE HYDROCHLORIDEPERRIGO R AND D CO2011-05-20ANDA091292_001
10NDA019037IMODIUMTrueJANSSEN PHARMACEUTICALS INC1984-07-31NDA019037_001Loperamide Oral Solution
Lorazepam Oral Solution
11NDA019487IMODIUM A-DJOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION1988-03-01NDA019487_001, NDA019487_002Loperamide Oral Solution
Lorazepam Oral Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA073062_001discontinuedLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1993-05-28LOPERAMIDE HYDROCHLORIDE
2ANDA073079_001OTCLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1992-04-30LOPERAMIDE HYDROCHLORIDE
3ANDA073187_001discontinuedLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1992-09-15LOPERAMIDE HYDROCHLORIDE
4ANDA073243_001OTCLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1992-01-21LOPERAMIDE HYDROCHLORIDE
5ANDA073478_001discontinuedLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1995-06-23LOPERAMIDE HYDROCHLORIDE
6ANDA074352_001OTCLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1995-11-17LOPERAMIDE HYDROCHLORIDE
7ANDA074730_001OTCLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1997-08-28LOPERAMIDE HYDROCHLORIDE
8ANDA074991_001discontinuedLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1997-12-29LOPERAMIDE HYDROCHLORIDE
9ANDA091292_001OTCLOPERAMIDE HYDROCHLORIDE (1MG/7.5ML)ORALSUSPENSIONFalse2011-05-20LOPERAMIDE HYDROCHLORIDE
10NDA019037_001discontinuedLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1984-07-31IMODIUM
11NDA019487_001OTCLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONTrue1988-03-01IMODIUM A-D
12NDA019487_002OTCLOPERAMIDE HYDROCHLORIDE (1MG/7.5ML)ORALSUSPENSIONTrue2004-07-08IMODIUM A-D

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11c0f455a-a52e-4762-baf7-a3ac741e08f9 (view SPL)CVS Pharmacy, Inc. Loperamide Hydrochloride Drug FactsotcHuman OTCCvs2015-09-212597790758
21f8a3818-53b8-4749-b330-56b0f3b90a8a (view SPL)Kroger Co. Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCKroger2015-01-195301420645
325e2d8e7-412d-4206-b2dc-9bf4af928d45 (view SPL)Meijer Distribution, Inc. Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCMeijer Distribution, Inc2014-06-263412500645
4261d89d1-37cb-4af9-ad82-7e79f8da2e7f (view SPL)American Sales Company Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCFoodhold U.S.A., Llc2014-10-214415200645
52845ad4d-0442-45dc-8599-da7b4c8b78f3 (view SPL)LOPERAMIDE HYDROCHLORIDE ORAL SUSPENSIONotcHuman OTCPrecision Dose Inc.2013-12-021680940107
62e7a424d-6626-4772-bb47-bd5d3dd181b3 (view SPL)Amerisource Bergen Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCAmerisource Bergen2014-03-061461220241
736605a13-e93e-4b25-a888-dc64c2130c2e (view SPL)Perrigo Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCL. Perrigo Company2014-06-173001130645
83fc5778f-a211-455c-878f-36fae523159c (view SPL)CVS Pharmacy, Inc. Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCCvs2015-10-095597790645
945b3d2da-5321-4188-a011-281d1ee3cbfa (view SPL)LOPERAMIDE HYDROCHLORIDE ORAL SUSPENSIONotcHuman OTCPrecision Dose Inc.2013-12-021680940108
1060546513-376c-4707-b554-2f65a0d24bc1 (view SPL)Dolgencorp, LLC Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCDolgencorp, Llc2014-04-113559100645
116270ee8b-fa2c-4f06-8eaf-fc81716d9921 (view SPL)Major Pharmaceuticals Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCPreferred Pharmaceuticals, Inc.RELABEL2015-01-282687889704
12629987c1-abf3-4149-afba-f306c55e44ad (view SPL)McKesson Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCMckesson (Health Mart)2014-06-171620110236
1365abebcc-f5e2-4bd5-bf37-20e0fb53dc4c (view SPL)Walgreen Co. Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCWalgreens2015-01-134003630645
146d67a0ed-3f4d-4462-be73-5267809c70c3 (view SPL)Major Pharmaceuticals Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCMajor2014-04-113009046256
156f421dda-eed1-41bd-98f2-ffa2fb41f6ec (view SPL)Cardinal Health Loperamide Hydrochloride Oral suspension Drug FactsotcHuman OTCCardinal Health, Inc.2014-05-301497810089
1676a976d5-8bee-4158-a94d-7fbfc5544fd4 (view SPL)Imodium A-DotcHuman OTCJohnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division2015-11-063505800134
1782b4ecac-7725-48e2-9cc2-ba856ed70d2e (view SPL)HEB Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCH-E-B2014-10-064378080645
188471db91-e87a-4399-a250-276a9f174fbd (view SPL)American Sales Company Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCFoodhold U.S.A., Llc2014-06-041415200758
1985a0f267-2a12-46cb-9d85-4fb0b34b4d74 (view SPL)Cardinal Health Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCCardinal Health2013-09-192372050584
20950fa674-1a6b-457d-a5ba-7c9166c77f33 (view SPL)Kmart Corporation Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCKmart Corp2014-10-064497380645
2195850912-0d07-46e4-88b7-57f2b800d2bd (view SPL)Kinray, LLC Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCPreferred Plus (Kinray)2014-06-091617150108
229f3faa14-3717-4c51-a28d-2bad40d4fc88 (view SPL)McKesson Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCSunmark2014-02-181493480999
23a2051c7f-dab8-4adc-97ce-e823830e0dc5 (view SPL)Harris Teeter, LLC Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCHarris Teeter, Llc2015-05-201692560645
24a3a81c6e-d4da-44fa-9839-357abc3b54c2 (view SPL)Western Family Loperamide Hydrochloride Drug FactsotcHuman OTCWestern Family2014-06-041553120758
25a3eda337-1930-4179-a8c1-7f8ef20827a4 (view SPL)Wal-Mart Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCWalmart2014-04-112490350645
26ae165253-41ef-463f-ab08-8f8b501264b6 (view SPL)Kinray, LLC Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCPreferred Plus (Kinray)2014-05-271617150107
27af1474cf-5ce2-400f-a975-c5904048dc5b (view SPL)McKesson Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCMckesson (Health Mart)2014-04-113620110151
28bce1bbaf-1f2c-4a53-9c20-67f0c7dddf6b (view SPL)Hy-Vee, Inc. Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCHy-Vee2014-06-173425070645
29c93d70ec-6f77-42ff-a461-b2f152011e86 (view SPL)Shopko Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCShopko Stores Operating Co, Llc2014-04-113370120645
30cfa6b8f7-d890-44ee-b27e-c0c538042461 (view SPL)Cardinal Health Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCCardinal Health, Inc.2014-04-231497810061
31d0f42e02-3b56-488a-a4dc-aaafa6b10259 (view SPL)Western Family Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCWestern Family2013-09-192553120645
32e09a277c-03b5-4d09-9058-a2d635e7d03c (view SPL)Topco Associates LLC. Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCTop Care (Topco Associates Llc)2014-06-173368000645
33ee097be5-c4aa-4584-bf6f-5c9dc2fc615c (view SPL)SuperValu Inc. Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCSupervalu, Inc2015-03-054411630645
34efb4ab17-7a75-4e1a-9078-457af14c473a (view SPL)Rite Aid Corporation Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCRite Aid2015-03-054118221645
35f033c0e6-25da-4290-8e9c-2f3eafdf3f03 (view SPL)Amerisource Bergen Loperamide Hydrochloride Oral Suspension Drug FactsotcHuman OTCAmerisource Bergen2014-04-113461220111

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