Gabapentin

Product NDC: 68462-127
11-digit product format: 684620127
Labeler code: 68462
Product ID: 68462-127_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: 800 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077662-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2006-08-18
A077662-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2006-08-18

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077662-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077662-002	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077662-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077662-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077662-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077662-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077662-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077662-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077662-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077662-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077662-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077662-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077662-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077662-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077662-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077662-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077662-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077662-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077662-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077662-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077662-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077662-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077662-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077662-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077662-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077662-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077662-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077662-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077662-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077662-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077662-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077662-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077662-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077662-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077662-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077662-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077662-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077662-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077662-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077662-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	800 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6CW7F3G59X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3865a6e3-112c-490c-82ac-35401336b16e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cdc2ae60-922e-452d-a42f-787fe4e2ed06	Product name	1	20250123
7059096a-4b9f-36c2-db50-bb5c723e6e9e	Product name	2	20250114
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68462-127-01	Gabapentin	100 in 1 BOTTLE	TABLET	100		21
68462-127-05	Gabapentin	500 in 1 BOTTLE	TABLET	500		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-127-01	EA - Each	68462-127	3d8f02ed-1dfe-4805-be1c-e0308f13bbc9	1	2012-07-24
68462-127-05	EA - Each	68462-127	ef76bf2e-39d3-4bf9-9603-2d8eddf6ff97	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL S6758UPPLY DBA QUALITY CARE PRODUCTS LLC]	3396
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL S6758UPPLY DBA QUALITY CARE PRODUCTS LLC]	3396
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	12
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	12
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	12
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	12
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	GABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	12
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	GABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	12
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	12
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	12
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	12
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	12
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]	6
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]	6
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]	6
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]	6
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]	6
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]	3
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET [PROFICIENT RX LP]	3
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET [PROFICIENT RX LP]	3
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]	3
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]	3
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN TABLET [PROFICIENT RX LP]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN TABLET [PROFICIENT RX LP]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET [PROFICIENT RX LP]	3
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	GABAPENTIN TABLET [PROFICIENT RX LP]	3
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	GABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	GABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	GABAPENTIN TABLET [PROFICIENT RX LP]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GABAPENTIN TABLET [PROFICIENT RX LP]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN TABLET [PROFICIENT RX LP]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET [PROFICIENT RX LP]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN TABLET [PROFICIENT RX LP]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN TABLET [PROFICIENT RX LP]	3
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET [PREFERRED PHARMACEUTICALS INC.]	1
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET [PREFERRED PHARMACEUTICALS INC.]	1
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN TABLET [PREFERRED PHARMACEUTICALS INC.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN TABLET [PREFERRED PHARMACEUTICALS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET [PREFERRED PHARMACEUTICALS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	GABAPENTIN TABLET [PREFERRED PHARMACEUTICALS INC.]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	GABAPENTIN TABLET [PREFERRED PHARMACEUTICALS INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GABAPENTIN TABLET [PREFERRED PHARMACEUTICALS INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN TABLET [PREFERRED PHARMACEUTICALS INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET [PREFERRED PHARMACEUTICALS INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN TABLET [PREFERRED PHARMACEUTICALS INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN TABLET [PREFERRED PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-127	GABAPENTIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	19	Current NDC, Legacy NDC, 2 package rows	20240904_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Coupler LLC	583ab038-7b6e-96f8-e063-6294a90adf47	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Unit Dose Solutions, Inc.	54edd6f3-06c7-a0c7-e063-6394a90a8b4f	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	4cb26d6e-7963-4fe5-903e-ab5180545066	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	BluePoint Laboratories	3368bf70-d466-4765-b2b7-7fe967a8c2b7	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	632cb507-5675-2392-0460-b09c0dd14650	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Glenmark Pharmaceuticals Inc., USA	3865a6e3-112c-490c-82ac-35401336b16e	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662 ndc (product): 68462-127
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	137b2b9a-9d42-48d0-913f-5dc146fb689a	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	2278ce1b-1c19-4ad2-89c6-4530f7b78ea7	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	7c3b232a-3e9f-4249-9e5a-295482ee288a	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Proficient Rx LP	c78f528f-9192-4037-bfb9-ff5718ed26c5	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6CW7F3G59X	GABAPENTIN	60142-96-3	GABAPENTIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310433	gabapentin 600 MG Oral Tablet	PSN	3865a6e3-112c-490c-82ac-35401336b16e	21
310434	gabapentin 800 MG Oral Tablet	PSN	3865a6e3-112c-490c-82ac-35401336b16e	21
310433	gabapentin 600 MG Oral Tablet	SCD	3865a6e3-112c-490c-82ac-35401336b16e	21
310434	gabapentin 800 MG Oral Tablet	SCD	3865a6e3-112c-490c-82ac-35401336b16e	21
310433	gabapentin 600 MG Oral Tablet	PSN	383fd4de-4d2a-42dc-9a15-48bee7efb0ba	7
310434	gabapentin 800 MG Oral Tablet	PSN	383fd4de-4d2a-42dc-9a15-48bee7efb0ba	7
310433	gabapentin 600 MG Oral Tablet	SCD	383fd4de-4d2a-42dc-9a15-48bee7efb0ba	7
310434	gabapentin 800 MG Oral Tablet	SCD	383fd4de-4d2a-42dc-9a15-48bee7efb0ba	7
310433	gabapentin 600 MG Oral Tablet	PSN	c78f528f-9192-4037-bfb9-ff5718ed26c5	6
310434	gabapentin 800 MG Oral Tablet	PSN	2278ce1b-1c19-4ad2-89c6-4530f7b78ea7	6
310434	gabapentin 800 MG Oral Tablet	PSN	c78f528f-9192-4037-bfb9-ff5718ed26c5	6
310433	gabapentin 600 MG Oral Tablet	SCD	c78f528f-9192-4037-bfb9-ff5718ed26c5	6
310434	gabapentin 800 MG Oral Tablet	SCD	2278ce1b-1c19-4ad2-89c6-4530f7b78ea7	6
310434	gabapentin 800 MG Oral Tablet	SCD	c78f528f-9192-4037-bfb9-ff5718ed26c5	6
310433	gabapentin 600 MG Oral Tablet	PSN	b4e95e49-2218-4150-bf23-71645114eb8c	4
310433	gabapentin 600 MG Oral Tablet	PSN	5dbdcf46-c0d9-4249-81fa-75bef5a69d84	4
310434	gabapentin 800 MG Oral Tablet	PSN	b4e95e49-2218-4150-bf23-71645114eb8c	4
310434	gabapentin 800 MG Oral Tablet	PSN	5dbdcf46-c0d9-4249-81fa-75bef5a69d84	4
310433	gabapentin 600 MG Oral Tablet	SCD	b4e95e49-2218-4150-bf23-71645114eb8c	4
310433	gabapentin 600 MG Oral Tablet	SCD	5dbdcf46-c0d9-4249-81fa-75bef5a69d84	4
310434	gabapentin 800 MG Oral Tablet	SCD	b4e95e49-2218-4150-bf23-71645114eb8c	4
310434	gabapentin 800 MG Oral Tablet	SCD	5dbdcf46-c0d9-4249-81fa-75bef5a69d84	4
310430	gabapentin 100 MG Oral Capsule	PSN	2e319a08-901d-40a9-e054-00144ff88e88	3
310431	gabapentin 300 MG Oral Capsule	PSN	2e319a08-901d-40a9-e054-00144ff88e88	3
310433	gabapentin 600 MG Oral Tablet	PSN	4e37278a-7d7f-4b6d-aaa6-1a808234af9e	3
310434	gabapentin 800 MG Oral Tablet	PSN	2e319a08-901d-40a9-e054-00144ff88e88	3
310434	gabapentin 800 MG Oral Tablet	PSN	4e37278a-7d7f-4b6d-aaa6-1a808234af9e	3
310430	gabapentin 100 MG Oral Capsule	SCD	2e319a08-901d-40a9-e054-00144ff88e88	3
310431	gabapentin 300 MG Oral Capsule	SCD	2e319a08-901d-40a9-e054-00144ff88e88	3
310433	gabapentin 600 MG Oral Tablet	SCD	4e37278a-7d7f-4b6d-aaa6-1a808234af9e	3
310434	gabapentin 800 MG Oral Tablet	SCD	2e319a08-901d-40a9-e054-00144ff88e88	3
310434	gabapentin 800 MG Oral Tablet	SCD	4e37278a-7d7f-4b6d-aaa6-1a808234af9e	3
310433	gabapentin 600 MG Oral Tablet	PSN	5ac5271e-316c-4802-a172-aa602d22571f	1
310434	gabapentin 800 MG Oral Tablet	PSN	5ac5271e-316c-4802-a172-aa602d22571f	1
310434	gabapentin 800 MG Oral Tablet	PSN	5a963df3-4c2b-71ce-e053-2a91aa0a1501	1
310434	gabapentin 800 MG Oral Tablet	PSN	7203ebe3-1692-9273-e053-2995a90a04c5	1
310434	gabapentin 800 MG Oral Tablet	PSN	4cb26d6e-7963-4fe5-903e-ab5180545066	1
310433	gabapentin 600 MG Oral Tablet	SCD	5ac5271e-316c-4802-a172-aa602d22571f	1
310434	gabapentin 800 MG Oral Tablet	SCD	4cb26d6e-7963-4fe5-903e-ab5180545066	1
310434	gabapentin 800 MG Oral Tablet	SCD	7203ebe3-1692-9273-e053-2995a90a04c5	1
310434	gabapentin 800 MG Oral Tablet	SCD	5a963df3-4c2b-71ce-e053-2a91aa0a1501	1
310434	gabapentin 800 MG Oral Tablet	SCD	5ac5271e-316c-4802-a172-aa602d22571f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-127-01	68462012701	100 TABLET in 1 BOTTLE (68462-127-01)	100 tablet	2006-04-01	0000-00-00	No	No	Current
68462-127-05	68462012705	500 TABLET in 1 BOTTLE (68462-127-05)	500 tablet	2006-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Bryant Ranch Prepack	2026-05-01	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited \| Appco Pharma LLC, USA (Unit-II)	2025-12-05	HUMAN PRESCRIPTION DRUG LABEL	21
Gabapentin	Bryant Ranch Prepack	2025-07-14	HUMAN PRESCRIPTION DRUG LABEL	6
GABAPENTIN	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	3
GABAPENTIN	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	2
Gabapentin	NCS HealthCare of KY, LLC dba Vangard Labs	2022-09-07	HUMAN PRESCRIPTION DRUG LABEL	3
Gabapentin	St. Mary's Medical Park Pharmacy \| Glenmark Pharmaceuticals Limited	2020-08-05	HUMAN PRESCRIPTION DRUG LABEL	5
Gabapentin	REMEDYREPACK INC.	2020-03-29	HUMAN PRESCRIPTION DRUG LABEL	10
Gabapentin Tablets USP	Proficient Rx LP	2019-10-01	HUMAN PRESCRIPTION DRUG LABEL	6
Gabapentin	Preferred Pharmaceuticals Inc.	2019-09-30	HUMAN PRESCRIPTION DRUG LABEL	4
Gabapentin Tablets USP	Quality Care Products, LLC	2019-07-29	HUMAN PRESCRIPTION DRUG LABEL	3399
GABAPENTIN	DIRECT RX	2019-04-11	HUMAN PRESCRIPTION DRUG LABEL	3
Gabapentin	Medsource Pharmaceuticals	2018-07-27	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin	NuCare Pharmaceuticals,Inc.	2017-12-07	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin	Unit Dose Services	2017-10-11	HUMAN PRESCRIPTION DRUG LABEL	4
Gabapentin	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2017-10-02	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin	NuCare Pharmaceuticals,Inc.	2017-09-12	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin	Blenheim Pharmacal, Inc.	2016-02-03	HUMAN PRESCRIPTION DRUG LABEL	7
Gabapentin Tablets USP	H.J. Harkins Company, Inc. \| Glenmark Generics Inc., USA \| Glenmark Generics Limited	2012-04-18	HUMAN PRESCRIPTION DRUG LABEL	3
Gabapentin Tablets USP	Rebel Distributors Corp \| PSS World Medical, Inc. \| STAT RX USA LLC \| Dispensing Solutions, Inc. \| SCRIPT PAK \| Keltman Pharmaceuticals, Inc. \| Rebel Distirbutors Corp.	2011-12-27	HUMAN PRESCRIPTION DRUG LABEL	4
Gabapentin - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-08-12	HUMAN PRESCRIPTION DRUG LABEL	1