Gabapentin

Product NDC: 0904-6665
Requested package NDC: 0904-6665-61
11-digit product format: 009046665
Labeler code: 0904
Product ID: 0904-6665_b6880b32-3ebc-4b0e-8a84-d513f3e401af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA090858
Marketing category: ANDA
Marketing start: 2011-01-29
Substance: GABAPENTIN
Active strength: 100 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 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
A090858-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17
A090858-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17
A090858-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090858-001	AB
A090858-002	AB
A090858-003	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	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`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	A090858-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090858-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090858-003	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 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Ascend Laboratories, LLC	722de2a9-38b3-4518-b262-ba0d1346d0ba	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a1006139-7dfc-4d87-a5a9-aeb380c32d24	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	896c7782-1137-454b-aaa6-28f42c7413ef	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	6a0a75ac-e121-477b-a9d1-d11f588afc9d	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	7652adc6-1aad-4422-b85c-0c6b11c23b73	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	d06380d0-c894-427e-b13e-5a8f9eb86a34	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	78445dbf-c7cd-419f-a7be-72821e496628	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Major Pharmaceuticals	36f74fdf-0dae-47a0-a7ea-e64ac91cd88f	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858 ndc (package): 0904-6665-61 ndc (product): 0904-6665 ndc11 (package): 00904666561
Gabapentin	GABAPENTIN	HAWAII REPACK, INC.	14d61caa-17ce-4fa2-90fb-1470f3864be8	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Northwind Health Company, LLC	552912b2-be59-0333-e063-6394a90a85c0	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Northwind Health Company, LLC	55292235-bf8f-46d0-e063-6294a90a91a5	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	3e633cd0-5ee8-4a05-bcfc-0a80209bf27f	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Unit Dose Solutions, Inc.	54ecc64b-f019-9fcb-e063-6294a90a00af	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	ddb3a54f-5224-4024-8804-b2a2f01d885e	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	41844c21-9e2a-4332-a8ff-9b71ae9032b0	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	A-S Medication Solutions	03031adf-d36b-45ec-944e-dfce5a5de91a	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	d4f21e97-5e55-44c9-9b31-5f79ac2eb512	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Major Pharmaceuticals	999f3685-2eac-467e-bed2-1d0c36aaf0ed	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	fce0c123-29d7-42bf-8c8d-8be1772e2d99	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	afc83432-8fce-6d2a-e053-2a95a90ae73f	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858

Additional Listing Data#

Finished product: Yes
Brand name base: Gabapentin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	100 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310430	Internal RxNorm lookup
310431	Internal RxNorm lookup
310432	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
36f74fdf-0dae-47a0-a7ea-e64ac91cd88f	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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-6665-61	Gabapentin	1 in 1 BLISTER PACK	CAPSULE	1		10
0904-6665-61	Gabapentin	100 in 1 CARTON	CAPSULE	100		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6665-61	EA - Each	0904-6665	831299bc-b535-4c0a-8070-6a16900e2186	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6665	GABAPENTIN CAPSULE [MAJOR PHARMACEUTICALS]	9	Current NDC, Legacy NDC, 2 package rows	20250224_36f74fdf-0dae-47a0-a7ea-e64ac91cd88f.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
310430	gabapentin 100 MG Oral Capsule	PSN	36f74fdf-0dae-47a0-a7ea-e64ac91cd88f	10
310430	gabapentin 100 MG Oral Capsule	PSN	41844c21-9e2a-4332-a8ff-9b71ae9032b0	10
310431	gabapentin 300 MG Oral Capsule	PSN	36f74fdf-0dae-47a0-a7ea-e64ac91cd88f	10
310431	gabapentin 300 MG Oral Capsule	PSN	41844c21-9e2a-4332-a8ff-9b71ae9032b0	10
310432	gabapentin 400 MG Oral Capsule	PSN	36f74fdf-0dae-47a0-a7ea-e64ac91cd88f	10
310432	gabapentin 400 MG Oral Capsule	PSN	41844c21-9e2a-4332-a8ff-9b71ae9032b0	10
310430	gabapentin 100 MG Oral Capsule	SCD	36f74fdf-0dae-47a0-a7ea-e64ac91cd88f	10
310430	gabapentin 100 MG Oral Capsule	SCD	41844c21-9e2a-4332-a8ff-9b71ae9032b0	10
310431	gabapentin 300 MG Oral Capsule	SCD	36f74fdf-0dae-47a0-a7ea-e64ac91cd88f	10
310431	gabapentin 300 MG Oral Capsule	SCD	41844c21-9e2a-4332-a8ff-9b71ae9032b0	10
310432	gabapentin 400 MG Oral Capsule	SCD	36f74fdf-0dae-47a0-a7ea-e64ac91cd88f	10
310432	gabapentin 400 MG Oral Capsule	SCD	41844c21-9e2a-4332-a8ff-9b71ae9032b0	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6665-61	00904666561	100 BLISTER PACK in 1 CARTON (0904-6665-61) / 1 CAPSULE in 1 BLISTER PACK	100 blister pack	2011-01-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Major Pharmaceuticals	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	11
Gabapentin	Cardinal Health 107, LLC	2026-06-18	HUMAN PRESCRIPTION DRUG LABEL	11