Gabapentin

Product NDC: 60505-0113
Requested package NDC: 60505-0113-8
11-digit product format: 605050113
Labeler code: 60505
Product ID: 60505-0113_495d183d-f43e-cd94-750f-632891121be7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA075360
Marketing category: ANDA
Marketing start: 2005-04-06
Marketing end: 2022-05-31
Substance: GABAPENTIN
Active strength: 300 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60505-0113	60505-0113-8	D	Discontinued by firm		2026-08-03
excluded package	package	60505-0113	60505-0113-8	D	Discontinued by firm		2026-08-03

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075360-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06
A075360-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06
A075360-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075360-001	AB
A075360-002	AB
A075360-003	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A075360-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075360-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075360-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	Granules Pharmaceuticals Inc	c681c804-c6f3-d63b-e053-2995a90a6b8f	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	397fd6d3-317b-4b61-a52b-3a09ca1d88a4	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	13640281-26b4-402e-8f69-7c81cd6e0376	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	ST. MARY'S MEDICAL PARK PHARMACY	3aaf3d6e-c6d5-89f5-e063-6394a90a9b77	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Granules Pharmaceuticals Inc.	b20ee34a-7f2d-4d62-a161-898565f74547	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	c859e666-d510-426b-e053-2995a90a9a3c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Asclemed USA, Inc.	5fb79774-c2d4-47ba-9a16-eb367d0fdcff	2023-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Proficient Rx LP	aa3ab216-372a-4a72-bfd1-88a1ffa31ba3	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Proficient Rx LP	185f264e-db32-41cd-b90d-519717b97850	2021-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0113-0	EA - Each	60505-0113	5147df3f-5ce5-461a-9ec7-05dc98854ff4	1	2012-07-24
60505-0113-1	EA - Each	60505-0113	c6614e60-3da0-42c0-b3f8-2f26d987936a	1	2012-07-24
60505-0113-7	EA - Each	60505-0113	2d86dcde-3ca4-44d9-b023-d25df88aa352	1	2012-07-24
60505-0113-8	EA - Each	60505-0113	6ff6194e-bcb9-420e-9691-ced4d82db1cd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1

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
310431	gabapentin 300 MG Oral Capsule	PSN	39ce8bbc-7df9-45f4-ab5a-b319d2b25c88	20
310431	gabapentin 300 MG Oral Capsule	SCD	39ce8bbc-7df9-45f4-ab5a-b319d2b25c88	20
310431	gabapentin 300 MG Oral Capsule	PSN	b61dcc9b-0a0e-4841-b4f5-2e04e433c609	11
310431	gabapentin 300 MG Oral Capsule	SCD	b61dcc9b-0a0e-4841-b4f5-2e04e433c609	11
310431	gabapentin 300 MG Oral Capsule	PSN	2550a291-51f6-473f-89cd-193bbe97662a	2
310432	gabapentin 400 MG Oral Capsule	PSN	2550a291-51f6-473f-89cd-193bbe97662a	2
310431	gabapentin 300 MG Oral Capsule	SCD	2550a291-51f6-473f-89cd-193bbe97662a	2
310432	gabapentin 400 MG Oral Capsule	SCD	2550a291-51f6-473f-89cd-193bbe97662a	2
310430	gabapentin 100 MG Oral Capsule	PSN	237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4	1
310431	gabapentin 300 MG Oral Capsule	PSN	237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4	1
310432	gabapentin 400 MG Oral Capsule	PSN	237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4	1
310430	gabapentin 100 MG Oral Capsule	SCD	237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4	1
310431	gabapentin 300 MG Oral Capsule	SCD	237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4	1
310432	gabapentin 400 MG Oral Capsule	SCD	237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0113-8	60505011308	1000 CAPSULE in 1 BOTTLE (60505-0113-8)	1000 capsule	2005-04-06	2022-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	A-S Medication Solutions	2021-02-04	HUMAN PRESCRIPTION DRUG LABEL	20
Gabapentin	Apotex Corp. \| Apotex Inc.	2021-01-13	HUMAN PRESCRIPTION DRUG LABEL	14
Gabapentin	A-S Medication Solutions	2018-06-28	HUMAN PRESCRIPTION DRUG LABEL	11
Gabapentin Capsules, USP 100 mg, 300 mg and 400 mg	Blenheim Pharmacal, Inc.	2013-12-31	HUMAN PRESCRIPTION DRUG LABEL	2
Gabapentin - Rebel Distributors Corp.	Rebel Distributors Corp.	2009-11-01	HUMAN PRESCRIPTION DRUG LABEL	1