Gabapentin

Product NDC: 71610-437
Requested package NDC: 71610-437-92
11-digit product format: 716100437
Labeler code: 71610
Product ID: 71610-437_389d28da-ee97-4aef-9697-7b3319685406
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA205101
Marketing category: ANDA
Marketing start: 2016-04-11
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 800 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71610-437	71610-437-92	I	Inactivated by FDA		2026-07-31

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
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

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71610-437-92	2023-01-30	C162847	48780-1	f386c64a-3723-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-437-92	Gabapentin	270 in 1 BOTTLE	TABLET	270		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-437-92	EA - Each	71610-437	174e85d7-cc90-45d9-befc-994ca85621e4	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-437	GABAPENTIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 1 package rows	20200709_08decd82-6f81-453c-b129-ecef80d4875c.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	08decd82-6f81-453c-b129-ecef80d4875c	1
310434	gabapentin 800 MG Oral Tablet	SCD	08decd82-6f81-453c-b129-ecef80d4875c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-437-92	71610043792	270 TABLET in 1 BOTTLE (71610-437-92)	270 tablet	2020-06-24	0000-00-00	No	No	Current