Gabapentin

Product NDC: 67046-1536
Requested package NDC: 67046-1536-3
11-digit product format: 670461536
Labeler code: 67046
Product ID: 67046-1536_3133e596-4212-c9cd-e063-6294a90a06f2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA205101
Marketing category: ANDA
Marketing start: 2025-03-25
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 1.

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
A205101-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2016-02-04
A205101-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2016-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205101-001	AB1
A205101-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1		2016-02-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1		2016-02-04	`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	A205101-001	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205101-002	AB1	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 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	9b175f8d-7667-4bfe-8bb5-fd7441eed456	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	HAWAII REPACK, INC.	f6ff265b-569b-4f5c-8fdb-00b7ad4aac7c	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	ba4d863d-be38-8cf5-e053-2995a90a69fb	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	c85ae572-9893-629e-e053-2995a90a23fc	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ce0f0d7f-da6d-47da-a4ed-fb8f72902412	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	abb56036-88df-4720-ba78-529971671545	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a75c9157-a1fc-44cc-89f8-c5a3742fb9ed	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	d1aa4690-57b5-4a3e-ac12-85f777dbd05e	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	75caca13-1432-4c0d-8d45-f029b0b2d417	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	56378630-e7a7-4981-8212-8ea703a433d8	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Radha Pharmaceuticals, Inc.	1045db4e-4c76-4a0d-bf12-019bd96a8f59	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	ScieGen Pharmaceuticals, Inc.	5ab9c18b-9568-4dcb-90b0-252aef8f8dc2	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals, Inc.	5d3f27bf-3486-40fa-a4d3-5f0b2c6c0151	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals, Inc.	561f53d5-5301-42b3-b372-f3d49d642a2e	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Coupler LLC	3133fc78-dd7a-880c-e063-6394a90a89e1	2025-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101 ndc (package): 67046-1536-3 ndc (product): 67046-1536 ndc11 (package): 67046153603
Gabapentin	GABAPENTIN	Directrx	d5c9dd2c-b8ee-1406-e053-2995a90a0287	2025-01-21	Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
GABAPENTIN	GABAPENTIN	DIRECT RX	a7e45e3f-e382-32ba-e053-2a95a90a2537	2025-01-17		Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Creekwood Pharmaceuticals LLC	266ef369-0a56-f225-e063-6294a90a495e	2024-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	a9c99dfa-f54d-9207-e053-2995a90ad43b	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	a9f0852e-0c58-ba22-e053-2995a90adfa0	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
3133fc78-dd7a-880c-e063-6394a90a89e1	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
67046-1536-3	Gabapentin	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-1536	GABAPENTIN TABLET [COUPLER LLC]	1	Current NDC, 1 package rows	20250327_3133fc78-dd7a-880c-e063-6394a90a89e1.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
310434	gabapentin 800 MG Oral Tablet	PSN	3133fc78-dd7a-880c-e063-6394a90a89e1	1
310434	gabapentin 800 MG Oral Tablet	SCD	3133fc78-dd7a-880c-e063-6394a90a89e1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1536-3	67046153603	30 TABLET in 1 BLISTER PACK (67046-1536-3)	30 tablet	2025-03-25	No	No	Current