Gabapentin

Product NDC
68462-126
11-digit product format
684620126
Labeler code
68462
Product ID
68462-126_4da1bae0-701b-4b65-a01e-f4bcedfad849
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA077662
Marketing category
ANDA
Marketing start
2006-04-01
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18caaa826d4ba7…
2026-08-18 06:07:402026-07A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077662-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A077662-002AB11caaa826d4ba7…
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6CW7F3G59XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310433Internal RxNorm lookup
310434Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3865a6e3-112c-490c-82ac-35401336b16eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-126-01Gabapentin100 in 1 BOTTLETABLET10021
68462-126-05Gabapentin500 in 1 BOTTLETABLET50021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-126-01EA - Each68462-126c1ff4524-8833-420f-ac64-3735dee5b3db12012-07-24
68462-126-05EA - Each68462-126c9847d13-ef0e-4bcc-80a3-9eb0cce79c8912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]12
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]12
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]12
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]12
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]12
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]12
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]12
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]12
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]6
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]6
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]6
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]6
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]6
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [PROFICIENT RX LP]3
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]3
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [PROFICIENT RX LP]3
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]3
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [PROFICIENT RX LP]3
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [PROFICIENT RX LP]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [PROFICIENT RX LP]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]3
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [BRYANT RANCH PREPACK]3
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [PROFICIENT RX LP]3
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [PROFICIENT RX LP]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [PROFICIENT RX LP]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [PROFICIENT RX LP]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [PROFICIENT RX LP]3
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [PROFICIENT RX LP]3
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [PROFICIENT RX LP]3
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [CONTRACT PHARMACY SERVICES-PA]2
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [CONTRACT PHARMACY SERVICES-PA]2
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [CONTRACT PHARMACY SERVICES-PA]2
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [CONTRACT PHARMACY SERVICES-PA]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [CONTRACT PHARMACY SERVICES-PA]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [TYA PHARMACEUTICALS]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [CONTRACT PHARMACY SERVICES-PA]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [CONTRACT PHARMACY SERVICES-PA]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [CONTRACT PHARMACY SERVICES-PA]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [CONTRACT PHARMACY SERVICES-PA]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [CONTRACT PHARMACY SERVICES-PA]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [CONTRACT PHARMACY SERVICES-PA]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [CONTRACT PHARMACY SERVICES-PA]2
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-126GABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]19Current NDC, Legacy NDC, 2 package rows20240904_3865a6e3-112c-490c-82ac-35401336b16e.zip

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
GabapentinGABAPENTINBluePoint Laboratories3368bf70-d466-4765-b2b7-7fe967a8c2b72026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINBryant Ranch Prepack632cb507-5675-2392-0460-b09c0dd146502026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINGlenmark Pharmaceuticals Inc., USA3865a6e3-112c-490c-82ac-35401336b16e2025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
ndc (product): 68462-126
GabapentinGABAPENTINBryant Ranch Prepack137b2b9a-9d42-48d0-913f-5dc146fb689a2025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
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
GabapentinGABAPENTINProficient Rx LPc78f528f-9192-4037-bfb9-ff5718ed26c52019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN7c3b232a-3e9f-4249-9e5a-295482ee288a26
310433gabapentin 600 MG Oral TabletSCD7c3b232a-3e9f-4249-9e5a-295482ee288a26
310433gabapentin 600 MG Oral TabletPSN3865a6e3-112c-490c-82ac-35401336b16e21
310434gabapentin 800 MG Oral TabletPSN3865a6e3-112c-490c-82ac-35401336b16e21
310433gabapentin 600 MG Oral TabletSCD3865a6e3-112c-490c-82ac-35401336b16e21
310434gabapentin 800 MG Oral TabletSCD3865a6e3-112c-490c-82ac-35401336b16e21
310433gabapentin 600 MG Oral TabletPSN632cb507-5675-2392-0460-b09c0dd1465019
310433gabapentin 600 MG Oral TabletSCD632cb507-5675-2392-0460-b09c0dd1465019
310433gabapentin 600 MG Oral TabletPSN137b2b9a-9d42-48d0-913f-5dc146fb689a11
310433gabapentin 600 MG Oral TabletSCD137b2b9a-9d42-48d0-913f-5dc146fb689a11
310433gabapentin 600 MG Oral TabletPSN383fd4de-4d2a-42dc-9a15-48bee7efb0ba7
310434gabapentin 800 MG Oral TabletPSN383fd4de-4d2a-42dc-9a15-48bee7efb0ba7
310433gabapentin 600 MG Oral TabletSCD383fd4de-4d2a-42dc-9a15-48bee7efb0ba7
310434gabapentin 800 MG Oral TabletSCD383fd4de-4d2a-42dc-9a15-48bee7efb0ba7
310433gabapentin 600 MG Oral TabletPSNc78f528f-9192-4037-bfb9-ff5718ed26c56
310433gabapentin 600 MG Oral TabletPSN1d382246-eec8-69cc-e054-00144ff8d46c6
310434gabapentin 800 MG Oral TabletPSNc78f528f-9192-4037-bfb9-ff5718ed26c56
310433gabapentin 600 MG Oral TabletSCDc78f528f-9192-4037-bfb9-ff5718ed26c56
310433gabapentin 600 MG Oral TabletSCD1d382246-eec8-69cc-e054-00144ff8d46c6
310434gabapentin 800 MG Oral TabletSCDc78f528f-9192-4037-bfb9-ff5718ed26c56
310433gabapentin 600 MG Oral TabletPSNb4e95e49-2218-4150-bf23-71645114eb8c4
310433gabapentin 600 MG Oral TabletPSN5dbdcf46-c0d9-4249-81fa-75bef5a69d844
310434gabapentin 800 MG Oral TabletPSNb4e95e49-2218-4150-bf23-71645114eb8c4
310434gabapentin 800 MG Oral TabletPSN5dbdcf46-c0d9-4249-81fa-75bef5a69d844
310433gabapentin 600 MG Oral TabletSCDb4e95e49-2218-4150-bf23-71645114eb8c4
310433gabapentin 600 MG Oral TabletSCD5dbdcf46-c0d9-4249-81fa-75bef5a69d844
310434gabapentin 800 MG Oral TabletSCDb4e95e49-2218-4150-bf23-71645114eb8c4
310434gabapentin 800 MG Oral TabletSCD5dbdcf46-c0d9-4249-81fa-75bef5a69d844
310433gabapentin 600 MG Oral TabletPSN4e37278a-7d7f-4b6d-aaa6-1a808234af9e3
310434gabapentin 800 MG Oral TabletPSN4e37278a-7d7f-4b6d-aaa6-1a808234af9e3
310433gabapentin 600 MG Oral TabletSCD4e37278a-7d7f-4b6d-aaa6-1a808234af9e3
310434gabapentin 800 MG Oral TabletSCD4e37278a-7d7f-4b6d-aaa6-1a808234af9e3
310433gabapentin 600 MG Oral TabletPSNe85790f2-8fab-4a2c-92fb-aeae6d6855a22
310433gabapentin 600 MG Oral TabletPSN2f45060b-ce5c-4869-87c0-fd7d2224e86c2
310433gabapentin 600 MG Oral TabletSCDe85790f2-8fab-4a2c-92fb-aeae6d6855a22
310433gabapentin 600 MG Oral TabletSCD2f45060b-ce5c-4869-87c0-fd7d2224e86c2
310433gabapentin 600 MG Oral TabletPSN5ac5271e-316c-4802-a172-aa602d22571f1
310433gabapentin 600 MG Oral TabletPSN3aa67116-d8fa-4fb1-8293-721a4574e4191
310434gabapentin 800 MG Oral TabletPSN5ac5271e-316c-4802-a172-aa602d22571f1
310433gabapentin 600 MG Oral TabletSCD5ac5271e-316c-4802-a172-aa602d22571f1
310433gabapentin 600 MG Oral TabletSCD3aa67116-d8fa-4fb1-8293-721a4574e4191
310434gabapentin 800 MG Oral TabletSCD5ac5271e-316c-4802-a172-aa602d22571f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-126-0168462012601100 TABLET in 1 BOTTLE (68462-126-01) 100 tablet2006-04-010000-00-00NoNoCurrent
68462-126-0568462012605500 TABLET in 1 BOTTLE (68462-126-05) 500 tablet2006-04-010000-00-00NoNoCurrent