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

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 Identifiers#

Field, Values table
Field	Values
Unii	6CW7F3G59X
Rxcui	310433, 310434

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 [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 [PROFICIENT RX LP]	3
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]	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 [H.J. HARKINS COMPANY, INC.]	3
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	GABAPENTIN TABLET [PROFICIENT RX LP]	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 [PROFICIENT RX LP]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]	3
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, 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
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET [PHYSICIANS TOTAL CARE, 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

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

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 Tablets USP	Proficient Rx LP	2019-10-01	HUMAN PRESCRIPTION DRUG LABEL	6
GABAPENTIN	DIRECT RX	2019-04-11	HUMAN PRESCRIPTION DRUG LABEL	3
Gabapentin	Medsource Pharmaceuticals	2018-07-27	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	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

Gabapentin

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#