repaglinide Oral Tablet

Brand(s)
Prandin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novo Nordisk (2014-10-15)
Oldest Current Product
2000-01-03
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\REPAGLINIDE
FDAOB
ORAL\TABLET\REPAGLINIDE
SPL Active
ORAL\TABLET\REPAGLINIDE
SPL Moiety
ORAL\TABLET\REPAGLINIDE

product(s) by strength(s)

repaglinide 0.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001690081PrandinNDANovo Nordisk2000-01-03REPAGLINIDEORALTABLETNDA0207414c1c212f-71a5-4dd3-81b2-cd9e2148774c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783121ANDAMylan Pharmaceuticals Inc.2013-08-27REPAGLINIDEORALTABLETANDA09025245422d96-1673-4419-bdb2-d127bb67fabc
2005740240ANDAPaddock Laboratories, Llc2013-08-09REPAGLINIDEORALTABLETANDA201189872b81a0-8c13-4848-85a8-50f12d8ffa26
3007815148ANDASandoz Inc2013-12-27REPAGLINIDEORALTABLETANDA078555b0de00af-5bef-4c43-b5a2-2fb6c4494638
4510790062ANDAMylan Institutional Inc.2013-11-21REPAGLINIDEORALTABLETANDA090252e2810375-0042-4265-bf6d-e7191b51d34e
5519910853ANDABreckenridge Pharmaceutical, Inc.2015-05-01REPAGLINIDEORALTABLETANDA091517f5904c23-fa89-4d3f-b3da-8186fba83df4
6572370157ANDACitron Pharma Llc2014-01-22REPAGLINIDEORALTABLETANDA203820d7673e22-0dbb-4395-ad60-943d249203a1
7658620670ANDAAurobindo Pharma Limited2014-01-22REPAGLINIDEORALTABLETANDA20382068064989-47ea-4ed5-a20e-43c4ef6ec271

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560303PrandinNDALake Erie Medical Dba Quality Care Products Llc2010-10-12REPAGLINIDEORALTABLET001690081NDA020741d6d6c0df-adbf-46a4-a709-091183a56ec2
2681513565PrandinNDACarilion Materials Management2000-01-03REPAGLINIDEORALTABLET001690081NDA020741813f781f-7db8-49ed-b4ed-a829c37eddb7

repaglinide 1 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001690082PrandinNDANovo Nordisk2000-01-03REPAGLINIDEORALTABLETNDA0207414c1c212f-71a5-4dd3-81b2-cd9e2148774c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783122ANDAMylan Pharmaceuticals Inc.2014-01-22REPAGLINIDEORALTABLETANDA09025245422d96-1673-4419-bdb2-d127bb67fabc
2005740241ANDAPaddock Laboratories, Llc2014-01-22REPAGLINIDEORALTABLETANDA201189872b81a0-8c13-4848-85a8-50f12d8ffa26
3007815149ANDASandoz Inc2014-01-22REPAGLINIDEORALTABLETANDA078555b0de00af-5bef-4c43-b5a2-2fb6c4494638
4510790539ANDAMylan Institutional Inc.2014-02-27REPAGLINIDEORALTABLETANDA090252e2810375-0042-4265-bf6d-e7191b51d34e
5519910854ANDABreckenridge Pharmaceutical, Inc.2015-05-01REPAGLINIDEORALTABLETANDA091517f5904c23-fa89-4d3f-b3da-8186fba83df4
6572370158ANDACitron Pharma Llc2014-01-22REPAGLINIDEORALTABLETANDA203820d7673e22-0dbb-4395-ad60-943d249203a1
7576640745ANDACaraco Pharmaceutical Laboratories, Ltd.2013-07-11REPAGLINIDEORALTABLETANDA077571457c2638-86cd-4afc-b562-eea925e9d42a
8658620671ANDAAurobindo Pharma Limited2014-01-22REPAGLINIDEORALTABLETANDA20382068064989-47ea-4ed5-a20e-43c4ef6ec271

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910719ANDAAvkare, Inc.2013-12-12REPAGLINIDEORALTABLET576640745ANDA077571bf91583e-016f-0b0a-a224-31bf5bc66dbc
2548686439PrandinNDAPhysicians Total Care, Inc.2000-01-03REPAGLINIDEORALTABLET001690082NDA020741034c35a5-c037-4ad8-82d1-aec4feac4c97
3551544575PrandinNDACardinal Health2000-01-03REPAGLINIDEORALTABLET001690082NDA02074137061e3e-5e7f-4958-aab8-462846dd6fc0
4680840954ANDAAmerican Health Packaging2015-03-30, 2015-09-01REPAGLINIDEORALTABLET576640745ANDA0775715573ed0f-bd0b-4edc-a9ae-44f6fee50a49, 954cb59b-c47a-4817-9707-f442388a0d47
5681513566PrandinNDACarilion Materials Management2000-01-03REPAGLINIDEORALTABLET001690082NDA020741e2a07020-a596-4282-bb7c-c9ebe6edcd61

repaglinide 2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001690084PrandinNDANovo Nordisk2000-01-03REPAGLINIDEORALTABLETNDA0207414c1c212f-71a5-4dd3-81b2-cd9e2148774c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783123ANDAMylan Pharmaceuticals Inc.2014-01-22REPAGLINIDEORALTABLETANDA09025245422d96-1673-4419-bdb2-d127bb67fabc
2005740242ANDAPaddock Laboratories, Llc2014-01-22REPAGLINIDEORALTABLETANDA201189872b81a0-8c13-4848-85a8-50f12d8ffa26
3007815150ANDASandoz Inc2014-01-22REPAGLINIDEORALTABLETANDA078555b0de00af-5bef-4c43-b5a2-2fb6c4494638
4510790555ANDAMylan Institutional Inc.2014-02-24REPAGLINIDEORALTABLETANDA090252e2810375-0042-4265-bf6d-e7191b51d34e
5519910855ANDABreckenridge Pharmaceutical, Inc.2015-05-01REPAGLINIDEORALTABLETANDA091517f5904c23-fa89-4d3f-b3da-8186fba83df4
6572370159ANDACitron Pharma Llc2014-01-22REPAGLINIDEORALTABLETANDA203820d7673e22-0dbb-4395-ad60-943d249203a1
7576640747ANDACaraco Pharmaceutical Laboratories, Ltd.2013-07-11REPAGLINIDEORALTABLETANDA077571457c2638-86cd-4afc-b562-eea925e9d42a
8658620672ANDAAurobindo Pharma Limited2014-01-22REPAGLINIDEORALTABLETANDA20382068064989-47ea-4ed5-a20e-43c4ef6ec271

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910720ANDAAvkare, Inc.2013-12-12REPAGLINIDEORALTABLET576640747ANDA077571bf91583e-016f-0b0a-a224-31bf5bc66dbc
2493490559PrandinNDARemedyrepack Inc.2011-10-04REPAGLINIDEORALTABLET001690084NDA02074121b73946-d12e-4a61-8eaa-4bf10bb31b98
3548685381PrandinNDAPhysicians Total Care, Inc.2000-01-03REPAGLINIDEORALTABLET001690084NDA020741034c35a5-c037-4ad8-82d1-aec4feac4c97
4680840967ANDAAmerican Health Packaging2015-03-30, 2015-09-01REPAGLINIDEORALTABLET576640747ANDA0775715573ed0f-bd0b-4edc-a9ae-44f6fee50a49, 954cb59b-c47a-4817-9707-f442388a0d47

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA077571REPAGLINIDESUN PHARMACEUTICAL INDUSTRIES INC2013-07-11ANDA077571_002, ANDA077571_003
2ANDA078555REPAGLINIDESANDOZ INC2013-11-22ANDA078555_001, ANDA078555_002, ANDA078555_003
3ANDA090008REPAGLINIDEACTAVIS TOTOWA LLC2014-01-22ANDA090008_001, ANDA090008_002, ANDA090008_003
4ANDA090252REPAGLINIDEMYLAN PHARMACEUTICALS INC2013-08-23ANDA090252_001, ANDA090252_002, ANDA090252_003
5ANDA091517REPAGLINIDESTANDARD CHEM AND PHARM CO LTD2015-04-24ANDA091517_001, ANDA091517_002, ANDA091517_003
6ANDA201189REPAGLINIDEPADDOCK LABORATORIES LLC2013-07-17ANDA201189_001, ANDA201189_002, ANDA201189_003
7ANDA203820REPAGLINIDEAUROBINDO PHARMA LTD2014-01-22ANDA203820_001, ANDA203820_002, ANDA203820_003
8NDA020741PRANDINNOVO NORDISK INC1997-12-22NDA020741_001, NDA020741_002, NDA020741_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077571_002RXREPAGLINIDE (1MG)ORALTABLETFalseAB2013-07-11REPAGLINIDE
2ANDA077571_003RXREPAGLINIDE (2MG)ORALTABLETFalseAB2013-07-11REPAGLINIDE
3ANDA078555_001RXREPAGLINIDE (0.5MG)ORALTABLETFalseAB2013-11-22REPAGLINIDE
4ANDA078555_002RXREPAGLINIDE (1MG)ORALTABLETFalseAB2014-01-22REPAGLINIDE
5ANDA078555_003RXREPAGLINIDE (2MG)ORALTABLETFalseAB2014-01-22REPAGLINIDE
6ANDA090008_001RXREPAGLINIDE (0.5MG)ORALTABLETFalseAB2014-01-22REPAGLINIDE
7ANDA090008_002RXREPAGLINIDE (1MG)ORALTABLETFalseAB2014-01-22REPAGLINIDE
8ANDA090008_003RXREPAGLINIDE (2MG)ORALTABLETFalseAB2014-01-22REPAGLINIDE
9ANDA090252_001RXREPAGLINIDE (0.5MG)ORALTABLETFalseAB2013-08-23REPAGLINIDE
10ANDA090252_002RXREPAGLINIDE (1MG)ORALTABLETFalseAB2014-01-22REPAGLINIDE
11ANDA090252_003RXREPAGLINIDE (2MG)ORALTABLETFalseAB2014-01-22REPAGLINIDE
12ANDA091517_001RXREPAGLINIDE (0.5MG)ORALTABLETFalseAB2015-04-24REPAGLINIDE
13ANDA091517_002RXREPAGLINIDE (1MG)ORALTABLETFalseAB2015-04-24REPAGLINIDE
14ANDA091517_003RXREPAGLINIDE (2MG)ORALTABLETFalseAB2015-04-24REPAGLINIDE
15ANDA201189_001RXREPAGLINIDE (0.5MG)ORALTABLETFalseAB2013-07-17REPAGLINIDE
16ANDA201189_002RXREPAGLINIDE (1MG)ORALTABLETFalseAB2014-01-22REPAGLINIDE
17ANDA201189_003RXREPAGLINIDE (2MG)ORALTABLETFalseAB2014-01-22REPAGLINIDE
18ANDA203820_001RXREPAGLINIDE (0.5MG)ORALTABLETFalseAB2014-01-22REPAGLINIDE
19ANDA203820_002RXREPAGLINIDE (1MG)ORALTABLETFalseAB2014-01-22REPAGLINIDE
20ANDA203820_003RXREPAGLINIDE (2MG)ORALTABLETFalseAB2014-01-22REPAGLINIDE
21NDA020741_001RXREPAGLINIDE (0.5MG)ORALTABLETFalseAB1997-12-22PRANDIN
22NDA020741_002RXREPAGLINIDE (1MG)ORALTABLETFalseAB1997-12-22PRANDIN
23NDA020741_003RXREPAGLINIDE (2MG)ORALTABLETTrueAB1997-12-22PRANDIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1034c35a5-c037-4ad8-82d1-aec4feac4c97 (view SPL)PRANDIN(repaglinide) Tablets (0.5, 1, and 2 mg)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2015-05-063548685381, 548686439
221b73946-d12e-4a61-8eaa-4bf10bb31b98 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-10-041493490559
337061e3e-5e7f-4958-aab8-462846dd6fc0 (view SPL)PRANDIN(repaglinide) Tablets (0.5, 1, and 2 mg)prescriptionHuman PrescriptionCardinal HealthREPACK2013-04-304551544575
445422d96-1673-4419-bdb2-d127bb67fabc (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-09-266003783121, 003783122, 003783123
5457c2638-86cd-4afc-b562-eea925e9d42a (view SPL)Repaglinide Tablets USPprescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.MANUFACTURE2014-12-173576640745, 576640747
64c1c212f-71a5-4dd3-81b2-cd9e2148774c (view SPL)PRANDIN(repaglinide) Tablets (0.5, 1, and 2 mg)prescriptionHuman PrescriptionNovo NordiskMANUFACTURE2014-10-158001690081, 001690082, 001690084
75573ed0f-bd0b-4edc-a9ae-44f6fee50a49 (view SPL)Repaglinide Tablets, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-08-141680840954, 680840967
868064989-47ea-4ed5-a20e-43c4ef6ec271 (view SPL)Rx onlyprescriptionHuman PrescriptionAurobindo Pharma LimitedAPI MANUFACTURE2015-03-022658620670, 658620671, 658620672
9813f781f-7db8-49ed-b4ed-a829c37eddb7 (view SPL)PRANDIN (repaglinide) Tablets (0.5, 1, and 2 mg) prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-04-112681513565
10872b81a0-8c13-4848-85a8-50f12d8ffa26 (view SPL)Repaglinide Tablets, USP (0.5 mg, 1 mg, and 2 mg)prescriptionHuman PrescriptionPaddock Laboratories, LlcMANUFACTURE2014-01-245005740240, 005740241, 005740242
11954cb59b-c47a-4817-9707-f442388a0d47 (view SPL)REPAGLINIDE TABLETS, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-02-231680840954, 680840967
12b0de00af-5bef-4c43-b5a2-2fb6c4494638 (view SPL)Repaglinide Tablets USP, 0.5 mg, 1 mg and 2 mgprescriptionHuman PrescriptionSandoz Inc2014-01-223007815148, 007815149, 007815150
13bf91583e-016f-0b0a-a224-31bf5bc66dbc (view SPL)REPAGLINIDE TABLETS, USP 1 mg and 2 mgRx onlyprescriptionHuman PrescriptionAvkare, Inc.2013-12-121422910719, 422910720
14d6d6c0df-adbf-46a4-a709-091183a56ec2 (view SPL)Prandin 0.5mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcmanufacture, relabel429353560303
15d7673e22-0dbb-4395-ad60-943d249203a1 (view SPL)Repaglinide Tablets, USP Rx onlyprescriptionHuman PrescriptionCitron Pharma Llc2015-10-031572370157, 572370158, 572370159
16e2810375-0042-4265-bf6d-e7191b51d34e (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2014-01-034510790062, 510790539, 510790555
17e2a07020-a596-4282-bb7c-c9ebe6edcd61 (view SPL)PRANDIN (repaglinide) Tablets (0.5, 1, and 2 mg) prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-04-112681513566
18f5904c23-fa89-4d3f-b3da-8186fba83df4 (view SPL)Repaglinide Tablets USP, 0.5 mg, 1 mg, and 2 mgprescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.MANUFACTURE2015-02-272519910853, 519910854, 519910855

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