zaleplon Oral Capsule

Brand(s)
Sonata
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Laboratories Div Pfizer Inc (2014-08-26)
Oldest Current Product
1999-08-13
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\ZALEPLON
FDAOB
ORAL\CAPSULE\ZALEPLON
SPL Active
ORAL\CAPSULE, GELATIN COATED\ZALEPLON
ORAL\CAPSULE\ZALEPLON
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\ZALEPLON
ORAL\CAPSULE\ZALEPLON

product(s) by strength(s)

zaleplon 10 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1607930146SonataNDAPfizer Laboratories Div Pfizer Inc1999-08-13ZALEPLONORALCAPSULENDA020859c8a6c478-1d05-47b2-c98d-99177395b762

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540085ANDARoxane Laboratories, Inc2008-06-06ZALEPLONORALCAPSULEANDA077237cadd9d75-2139-4fab-94ce-2992e6a55780
2000935269ANDATeva Pharmaceuticals Usa Inc2008-06-06ZALEPLONORALCAPSULEANDA07723971be4cb7-a42f-43be-9b9b-f090edb2fd21
3003786810ANDAMylan Pharmaceuticals Inc.2008-06-06ZALEPLONORALCAPSULEANDA0772389780fed5-d051-46c5-851b-9b8800eb43bf
4008320401ANDAUpsher-Smith Laboratories, Inc.2008-06-06ZALEPLONORALCAPSULE, GELATIN COATEDANDA0787069f581c98-0631-414e-9676-0865a66dbc44
5167140561ANDANorthstar Rx Llc2010-06-23ZALEPLONORALCAPSULEANDA090374e7f5010b-aad0-4036-b60f-bfa1360facf0
6658620215ANDAAurobindo Pharma Limited2008-06-06ZALEPLONORALCAPSULEANDA078829e092f3ca-bf44-4568-a72c-3fb2cf5b192b
7678770211ANDAAscend Laboratories, Llc2010-12-15ZALEPLONORALCAPSULEANDA0789892f44db39-e1d9-451e-ba31-e4b10366a430

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950105NDARebel Distributors Corp2008-05-01ZALEPLONORALCAPSULE647200322NDA020859bc7639e9-c2cb-47bb-a295-efb0f656ccd1
2332610454ANDAAidarex Pharmaceuticals Llc2009-05-05ZALEPLONORALCAPSULE293000132ANDA078989423a4d98-f648-4eed-bd20-857c5a8dde5b
3353560573NDALake Erie Medical Dba Quality Care Products Llc2011-12-05ZALEPLONORALCAPSULE647200322NDA020859635e080f-352b-4d5c-852e-bac808e8b66a
4353560656ANDALake Erie Medical Dba Quality Care Products Llc2009-05-05ZALEPLONORALCAPSULE293000132ANDA0789892a764519-f8d9-4405-96b8-7d4b1b655075
5422540147ANDARebel Distributors Corp2009-05-05ZALEPLONORALCAPSULE293000132ANDA078989b9c6ed9c-c081-4a05-8f5e-bf646cfd5396
6500901126ANDAA-S Medication Solutions Llc2008-06-06ZALEPLONORALCAPSULE000540085ANDA077237ca4103e1-7391-463a-be42-6eabc860b972
7504361006ANDAUnit Dose Services2008-06-06ZALEPLONORALCAPSULE000935269ANDA077239ae18924a-606e-403b-a28b-7036ca9a8f45
8529590957ANDAH.J. Harkins Company, Inc.2010-12-15ZALEPLONORALCAPSULE678770211ANDA0789894ccb8d3d-31ef-49ff-8567-c620b9d74f8c
9545696118ANDAA-S Medication Solutions Llc2008-06-06ZALEPLONORALCAPSULE000935269ANDA0772393d795a06-1969-4d1b-9bbf-4d4ad02a5629
10548684431SonataNDAPhysicians Total Care, Inc.2004-04-01ZALEPLONORALCAPSULE607930146NDA02085943ac81cb-1e3f-4d44-86bd-13db2721d060
11548685908ANDAPhysicians Total Care, Inc.2008-06-19ZALEPLONORALCAPSULE658620215ANDA0788298fef39a1-b4bf-4583-b6f2-5b89990c6c86
12607600211ANDASt Marys Medical Park Pharmacy2010-12-15ZALEPLONORALCAPSULE678770211ANDA0789890d1d5797-6a7f-4a25-b13d-009224cc59c1
13619190629ANDADirect Rx2015-01-01ZALEPLONORALCAPSULE293000132ANDA078989d4871d67-cdf5-4801-9349-9ec4146df49f
14636293405ANDABryant Ranch Prepack2009-05-05ZALEPLONORALCAPSULE293000132ANDA078989b8032b14-5068-19d5-e063-839ed25d7200

zaleplon 5 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1607930145SonataNDAPfizer Laboratories Div Pfizer Inc1999-08-13ZALEPLONORALCAPSULENDA020859c8a6c478-1d05-47b2-c98d-99177395b762

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540084ANDARoxane Laboratories, Inc2008-06-06ZALEPLONORALCAPSULEANDA077237cadd9d75-2139-4fab-94ce-2992e6a55780
2000935268ANDATeva Pharmaceuticals Usa Inc2008-06-06ZALEPLONORALCAPSULEANDA07723971be4cb7-a42f-43be-9b9b-f090edb2fd21
3003786805ANDAMylan Pharmaceuticals Inc.2008-06-06ZALEPLONORALCAPSULEANDA0772389780fed5-d051-46c5-851b-9b8800eb43bf
4008320400ANDAUpsher-Smith Laboratories, Inc.2008-06-06ZALEPLONORALCAPSULE, GELATIN COATEDANDA0787069f581c98-0631-414e-9676-0865a66dbc44
5167140551ANDANorthstar Rx Llc2010-06-23ZALEPLONORALCAPSULEANDA090374e7f5010b-aad0-4036-b60f-bfa1360facf0
6293000131ANDAUnichem Pharmaceuticals (Usa), Inc.2009-05-05ZALEPLONORALCAPSULEANDA07898957a1a11d-7767-4caf-b98a-75d7561d9165
7658620214ANDAAurobindo Pharma Limited2008-06-06ZALEPLONORALCAPSULEANDA078829e092f3ca-bf44-4568-a72c-3fb2cf5b192b
8678770210ANDAAscend Laboratories, Llc2010-12-15ZALEPLONORALCAPSULEANDA0789892f44db39-e1d9-451e-ba31-e4b10366a430

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950376NDARebel Distributors Corp2008-05-01ZALEPLONORALCAPSULE647200322NDA020859bc7639e9-c2cb-47bb-a295-efb0f656ccd1
2332610486ANDAAidarex Pharmaceuticals Llc2009-05-05ZALEPLONORALCAPSULE293000131ANDA078989423a4d98-f648-4eed-bd20-857c5a8dde5b
3422540130ANDARebel Distributors Corp2009-05-05ZALEPLONORALCAPSULE678770210ANDA0789895fc5f29a-51e3-4f28-8b22-2ba9a7e64e7c
4422540189ANDARebel Distributors Corp2009-05-05ZALEPLONORALCAPSULE293000131ANDA078989f493f828-9fdd-4723-9fc7-f691d3879696
5430630240ANDAPd-Rx Pharmaceuticals, Inc.2011-12-02ZALEPLONORALCAPSULE003786805ANDA077238cd2786c3-2f9b-4d57-a1da-40af84d82fb6
6430630505ANDAPd-Rx Pharmaceuticals, Inc.2008-06-06ZALEPLONORALCAPSULE658620214ANDA0788299c83b71e-8344-4c77-b7f6-a9c862f9e7dd
7548685139SonataNDAPhysicians Total Care, Inc.2007-09-05ZALEPLONORALCAPSULE607930145NDA02085943ac81cb-1e3f-4d44-86bd-13db2721d060
8548685909ANDAPhysicians Total Care, Inc.2008-06-19ZALEPLONORALCAPSULE658620214ANDA0788298fef39a1-b4bf-4583-b6f2-5b89990c6c86
9636293906NDABryant Ranch Prepack2008-05-01ZALEPLONORALCAPSULE647200322NDA020859132b0305-07a5-17e9-17c5-a405706567fe
10663360056ANDADispensing Solutions, Inc.2008-06-06ZALEPLONORALCAPSULE000935268ANDA077239ec68d050-be3f-4150-9f86-22c957dddb91

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA077237ZALEPLONROXANE LABORATORIES INC2008-06-06ANDA077237_001, ANDA077237_002
2ANDA077238ZALEPLONMYLAN PHARMACEUTICALS INC2008-06-06ANDA077238_001, ANDA077238_002
3ANDA077239ZALEPLONTEVA PHARMACEUTICALS USA2008-06-06ANDA077239_001, ANDA077239_002
4ANDA077505ZALEPLONCIPLA LTD2008-06-20ANDA077505_001, ANDA077505_002
5ANDA078095ZALEPLONTrueSANDOZ INC2008-06-06ANDA078095_001, ANDA078095_002
6ANDA078147ZALEPLONHIKMA PHARMACEUTICALS LLC2008-11-25ANDA078147_001, ANDA078147_002
7ANDA078706ZALEPLONUPSHER SMITH LABORATORIES INC2008-06-06ANDA078706_001, ANDA078706_002
8ANDA078829ZALEPLONAUROBINDO PHARMA LTD2008-06-06ANDA078829_001, ANDA078829_002
9ANDA078989ZALEPLONUNICHEM LABORATORIES LTD2008-06-06ANDA078989_001, ANDA078989_002
10ANDA090374ZALEPLONORCHID HEALTHCARE2009-09-17ANDA090374_001, ANDA090374_002
11NDA020859SONATAPFIZER INC1999-08-13NDA020859_001, NDA020859_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077237_001RXZALEPLON (5MG)ORALCAPSULEFalseAB2008-06-06ZALEPLON
2ANDA077237_002RXZALEPLON (10MG)ORALCAPSULEFalseAB2008-06-06ZALEPLON
3ANDA077238_001RXZALEPLON (5MG)ORALCAPSULEFalseAB2008-06-06ZALEPLON
4ANDA077238_002RXZALEPLON (10MG)ORALCAPSULEFalseAB2008-06-06ZALEPLON
5ANDA077239_001RXZALEPLON (5MG)ORALCAPSULEFalseAB2008-06-06ZALEPLON
6ANDA077239_002RXZALEPLON (10MG)ORALCAPSULEFalseAB2008-06-06ZALEPLON
7ANDA077505_001RXZALEPLON (5MG)ORALCAPSULEFalseAB2008-06-20ZALEPLON
8ANDA077505_002RXZALEPLON (10MG)ORALCAPSULEFalseAB2008-06-20ZALEPLON
9ANDA078095_001discontinuedZALEPLON (5MG)ORALCAPSULEFalse2008-06-06ZALEPLON
10ANDA078095_002discontinuedZALEPLON (10MG)ORALCAPSULEFalse2008-06-06ZALEPLON
11ANDA078147_001RXZALEPLON (5MG)ORALCAPSULEFalseAB2008-11-25ZALEPLON
12ANDA078147_002RXZALEPLON (10MG)ORALCAPSULEFalseAB2008-11-25ZALEPLON
13ANDA078706_001RXZALEPLON (5MG)ORALCAPSULEFalseAB2008-06-06ZALEPLON
14ANDA078706_002RXZALEPLON (10MG)ORALCAPSULEFalseAB2008-06-06ZALEPLON
15ANDA078829_001RXZALEPLON (5MG)ORALCAPSULEFalseAB2008-06-06ZALEPLON
16ANDA078829_002RXZALEPLON (10MG)ORALCAPSULEFalseAB2008-06-06ZALEPLON
17ANDA078989_001RXZALEPLON (5MG)ORALCAPSULEFalseAB2008-06-06ZALEPLON
18ANDA078989_002RXZALEPLON (10MG)ORALCAPSULEFalseAB2008-06-06ZALEPLON
19ANDA090374_001RXZALEPLON (5MG)ORALCAPSULEFalseAB2009-09-17ZALEPLON
20ANDA090374_002RXZALEPLON (10MG)ORALCAPSULEFalseAB2009-09-17ZALEPLON
21NDA020859_001RXZALEPLON (5MG)ORALCAPSULEFalseAB1999-08-13SONATA
22NDA020859_002RXZALEPLON (10MG)ORALCAPSULETrueAB1999-08-13SONATA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10d1d5797-6a7f-4a25-b13d-009224cc59c1 (view SPL)ZALEPLON - zaleplone capsuleCIVRx OnlyprescriptionHuman PrescriptionSt Marys Medical Park PharmacyMANUFACTURE, relabel, repack2011-09-084607600211
2132b0305-07a5-17e9-17c5-a405706567fe (view SPL)Zaleplon CapsulesprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2008-05-012636293906
32a764519-f8d9-4405-96b8-7d4b1b655075 (view SPL)Zaleplon CapsulesprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcREPACK2012-07-313951353560656
42f44db39-e1d9-451e-ba31-e4b10366a430 (view SPL)ZALEPLON - zaleplone capsuleCIVRx OnlyprescriptionHuman PrescriptionAscend Laboratories, LlcMANUFACTURE2010-12-011678770210, 678770211
53d795a06-1969-4d1b-9bbf-4d4ad02a5629 (view SPL)ZALEPLON CAPSULES CIV52685269Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-05-161545696118
6423a4d98-f648-4eed-bd20-857c5a8dde5b (view SPL)Zaleplon CapsulesprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-311332610454, 332610486
743ac81cb-1e3f-4d44-86bd-13db2721d060 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-05-272548684431, 548685139
84ccb8d3d-31ef-49ff-8567-c620b9d74f8c (view SPL)ZALEPLON - zaleplone capsuleCIVRx OnlyprescriptionHuman PrescriptionH.J. Harkins Company, Inc.MANUFACTURE2011-08-311529590957
957a1a11d-7767-4caf-b98a-75d7561d9165 (view SPL)Zaleplon Capsules USPprescriptionHuman PrescriptionUnichem Pharmaceuticals (Usa), Inc.2015-08-055293000131
105fc5f29a-51e3-4f28-8b22-2ba9a7e64e7c (view SPL)Zaleplon CapsulesprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-01-241422540130
11635e080f-352b-4d5c-852e-bac808e8b66a (view SPL)Zaleplon Capsules5 mg and 10 mgCIVRx onlyprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcmanufacture, relabel, repack2011-12-053316353560573
1271be4cb7-a42f-43be-9b9b-f090edb2fd21 (view SPL)ZALEPLON CAPSULES USP CIV 52685269 Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-10-015000935268, 000935269
138fef39a1-b4bf-4583-b6f2-5b89990c6c86 (view SPL)Zaleplon Capsules CIVprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-05-231548685908, 548685909
149780fed5-d051-46c5-851b-9b8800eb43bf (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-10-236003786805, 003786810
159c83b71e-8344-4c77-b7f6-a9c862f9e7dd (view SPL)Zaleplon Capsules CIVprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2013-05-177430630505
169f581c98-0631-414e-9676-0865a66dbc44 (view SPL)Zaleplon Capsules CIVprescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.ANALYSIS, MANUFACTURE2014-04-103008320400, 008320401
17ae18924a-606e-403b-a28b-7036ca9a8f45 (view SPL)ZALEPLON CAPSULES CIV 5268 5269 Rx onlyprescriptionHuman PrescriptionUnit Dose ServicesREPACK2012-07-192504361006
18b8032b14-5068-19d5-e063-839ed25d7200 (view SPL)Zaleplon CapsulesprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-122636293405
19b9c6ed9c-c081-4a05-8f5e-bf646cfd5396 (view SPL)Zaleplon CapsulesprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-02-091422540147
20bc7639e9-c2cb-47bb-a295-efb0f656ccd1 (view SPL)Zaleplon Capsules5 mg and 10 mgCIVRx onlyprescriptionHuman PrescriptionRebel Distributors Corprelabel, repack2009-10-101216950105, 216950376
21c8a6c478-1d05-47b2-c98d-99177395b762 (view SPL)Sonata(zaleplon)CapsulesprescriptionHuman PrescriptionPfizer Laboratories Div Pfizer IncANALYSIS, LABEL, MANUFACTURE, PACK2014-08-2610607930145, 607930146
22ca4103e1-7391-463a-be42-6eabc860b972 (view SPL)prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2015-01-261500901126
23cadd9d75-2139-4fab-94ce-2992e6a55780 (view SPL)prescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2010-07-095000540084, 000540085
24cd2786c3-2f9b-4d57-a1da-40af84d82fb6 (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-06-012430630240
25d4871d67-cdf5-4801-9349-9ec4146df49f (view SPL)ZALEPLONprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-08-132619190629
26e092f3ca-bf44-4568-a72c-3fb2cf5b192b (view SPL)Zaleplon Capsules USPCIVprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-03-137658620214, 658620215
27e7f5010b-aad0-4036-b60f-bfa1360facf0 (view SPL)Zaleplon Capsules, USP CIVprescriptionHuman PrescriptionNorthstar Rx Llcanalysis, label, manufacture, pack2014-11-288167140551, 167140561
28ec68d050-be3f-4150-9f86-22c957dddb91 (view SPL)ZALEPLON CAPSULES CIV52685269Rx onlyprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-10-312663360056
29f493f828-9fdd-4723-9fc7-f691d3879696 (view SPL)Zaleplon CapsulesprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-03-201422540189

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