Application 077662

Type
ANDA
Sponsor
GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINTABLET;ORAL600MGNoNo
002GABAPENTINGABAPENTINTABLET;ORAL800MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077662-001GABAPENTINGABAPENTIN600MGTABLET / ORALAB12006-08-18
A077662-002GABAPENTINGABAPENTIN800MGTABLET / ORALAB12006-08-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077662-001AB1
A077662-002AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-18782e0a99824c…
2021-12-28 21:50 UTC2021-12A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-18782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077662-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077662-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077662-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077662-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077662-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077662-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077662-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077662-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077662-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077662-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077662-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077662-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077662-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077662-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077662-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077662-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077662-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077662-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077662-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077662-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077662-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077662-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077662-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077662-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077662-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077662-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077662-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077662-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077662-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077662-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077662-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077662-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077662-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077662-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077662-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077662-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077662-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077662-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077662-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077662-002AB1782e0a99824c…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINCoupler LLC583ab038-7b6e-96f8-e063-6294a90adf472026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINUnit Dose Solutions, Inc.54edd6f3-06c7-a0c7-e063-6394a90a8b4f2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINBryant Ranch Prepack4cb26d6e-7963-4fe5-903e-ab51805450662026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
ndc (product): 63629-7308
GabapentinGABAPENTINBluePoint Laboratories3368bf70-d466-4765-b2b7-7fe967a8c2b72026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
ndc (product): 68001-411
ndc (product): 68001-412
GabapentinGABAPENTINBryant Ranch Prepack632cb507-5675-2392-0460-b09c0dd146502026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
ndc (product): 63629-3063
GabapentinGABAPENTINGlenmark Pharmaceuticals Inc., USA3865a6e3-112c-490c-82ac-35401336b16e2025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
ndc (product): 68462-126
ndc (product): 68462-127
GabapentinGABAPENTINBryant Ranch Prepack137b2b9a-9d42-48d0-913f-5dc146fb689a2025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
ndc (product): 63629-7307
GabapentinGABAPENTINBryant Ranch Prepack2278ce1b-1c19-4ad2-89c6-4530f7b78ea72025-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.7c3b232a-3e9f-4249-9e5a-295482ee288a2025-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
ndc (product): 55289-959
GabapentinGABAPENTINProficient Rx LPc78f528f-9192-4037-bfb9-ff5718ed26c52019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
ndc (product): 63187-010
ndc (product): 63187-057

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 93 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8019GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8098GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8098GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8132GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8132GabapentinGabapentinNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8233GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8233GabapentinGabapentinNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
10544-439GabapentinGabapentinBlenheim Pharmacal, Inc.ANDACurrent
10544-448GabapentinGabapentinBlenheim Pharmacal, Inc.ANDACurrent
42254-054GabapentinGabapentinRebel Distributors CorpANDACurrent
42254-109GabapentinGabapentinRebel Distributors CorpANDACurrent
45865-356GabapentinGabapentinMedsource PharmaceuticalsANDACurrent
45865-356GabapentinGabapentinMedsource PharmaceuticalsANDACurrent
45865-405GabapentinGabapentinMedsource PharmaceuticalsANDACurrent
49999-784GabapentinGabapentinLake Erie Medica & Surgical Supply DBA Quality Care Products LLCANDACurrent
49999-799GabapentinGabapentinLake Erie Medical & Surgical S6758upply DBA Quality Care Products LLCANDACurrent
49999-799GabapentinGabapentinQuality Care Products, LLCANDACurrent
50436-0126GabapentinGabapentinUnit Dose ServicesANDACurrent
50436-7210GabapentinGabapentinUnit Dose ServicesANDACurrent
52959-772GabapentinGabapentinH.J. Harkins Company, Inc.ANDACurrent
52959-789GabapentinGabapentinH.J. Harkins Company, Inc.ANDACurrent
53217-282GabapentinGabapentinAidarex Pharmaceuticals LLCANDACurrent
55289-959GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-959GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-959GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-959GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-959GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-959GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-959GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
60760-123GabapentinGabapentinSt. Mary's Medical Park PharmacyANDACurrent
60760-123GabapentinGabapentinSt. Mary's Medical Park PharmacyANDACurrent
60760-173GabapentinGabapentinSt. MaryANDACurrent
60760-173GabapentinGabapentinSt. MaryANDACurrent
61919-350GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-350GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-350GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-350GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-350GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-350GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-350GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-677GABAPENTINGABAPENTINDIRECTRXANDACurrent
63187-010GabapentinGabapentinProficient Rx LPANDACurrent
63187-010GabapentinGabapentinProficient Rx LPANDACurrent
63187-057GabapentinGabapentinProficient Rx LPANDACurrent
63187-057GabapentinGabapentinProficient Rx LPANDACurrent
63629-3063GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-3063GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-3063GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7307GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7307GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7308GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7308GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7666GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7666GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7666GabapentinGabapentinBryant Ranch PrepackANDACurrent
64725-0126GabapentinGabapentinTYA PharmaceuticalsANDACurrent
67046-227GabapentinGabapentinContract Pharmacy Services-PAANDACurrent
67046-229GabapentinGabapentinContract Pharmacy Services-PAANDACurrent
68001-411GabapentinGabapentinBluePoint LaboratoriesANDACurrent
68001-411GabapentinGabapentinBluePoint LaboratoriesANDACurrent
68001-411GabapentinGabapentinBluePoint LaboratoriesANDACurrent
68001-412GabapentinGabapentinBluePoint LaboratoriesANDACurrent
68001-412GabapentinGabapentinBluePoint LaboratoriesANDACurrent
68001-412GabapentinGabapentinBluePoint LaboratoriesANDACurrent
68071-1292GabapentinGabapentinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1292GabapentinGabapentinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1292GabapentinGabapentinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4087GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4180GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68462-126GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-126GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-126GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-126GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-126GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-127GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-127GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-127GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-127GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-127GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68788-9023GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent