GABAPENTIN

Product NDC: 71335-2004
11-digit product format: 713352004
Labeler code: 71335
Product ID: 71335-2004_da9c203e-576a-4c73-b509-b31c44021046
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GABAPENTIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA075360
Marketing category: ANDA
Marketing start: 2020-09-07
Substance: GABAPENTIN
Active strength: 300 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 4 · 126 observed 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
2026-08-18 06:07:40	2026-07	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075360-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075360-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075360-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075360-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075360-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075360-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075360-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075360-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075360-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075360-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	300 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
310431	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
13640281-26b4-402e-8f69-7c81cd6e0376	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
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-2004-1	GABAPENTIN	90 in 1 BOTTLE	CAPSULE	90	104
71335-2004-2	GABAPENTIN	28 in 1 BOTTLE	CAPSULE	28	104
71335-2004-3	GABAPENTIN	58 in 1 BOTTLE	CAPSULE	58	104
71335-2004-4	GABAPENTIN	30 in 1 BOTTLE	CAPSULE	30	104
71335-2004-5	GABAPENTIN	60 in 1 BOTTLE	CAPSULE	60	104
71335-2004-6	GABAPENTIN	120 in 1 BOTTLE	CAPSULE	120	104
71335-2004-7	GABAPENTIN	180 in 1 BOTTLE	CAPSULE	180	104
71335-2004-8	GABAPENTIN	40 in 1 BOTTLE	CAPSULE	40	104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-2004-1	EA - Each	71335-2004	940d33b6-dae6-4230-a0f6-cbf22f380775	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-2004	GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 8 package rows	20231118_13640281-26b4-402e-8f69-7c81cd6e0376.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 ndc (product): 71335-2004
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

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	13640281-26b4-402e-8f69-7c81cd6e0376	104
310431	gabapentin 300 MG Oral Capsule	SCD	13640281-26b4-402e-8f69-7c81cd6e0376	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-2004-1	71335200401	90 CAPSULE in 1 BOTTLE (71335-2004-1)	90 capsule	2022-02-10	0000-00-00	No	No	Current
71335-2004-2	71335200402	28 CAPSULE in 1 BOTTLE (71335-2004-2)	28 capsule	2022-02-10	0000-00-00	No	No	Current
71335-2004-3	71335200403	58 CAPSULE in 1 BOTTLE (71335-2004-3)	58 capsule	2022-02-10	0000-00-00	No	No	Current
71335-2004-4	71335200404	30 CAPSULE in 1 BOTTLE (71335-2004-4)	30 capsule	2022-02-10	0000-00-00	No	No	Current
71335-2004-5	71335200405	60 CAPSULE in 1 BOTTLE (71335-2004-5)	60 capsule	2022-02-10	0000-00-00	No	No	Current
71335-2004-6	71335200406	120 CAPSULE in 1 BOTTLE (71335-2004-6)	120 capsule	2022-02-10	0000-00-00	No	No	Current
71335-2004-7	71335200407	180 CAPSULE in 1 BOTTLE (71335-2004-7)	180 capsule	2022-02-10	0000-00-00	No	No	Current
71335-2004-8	71335200408	40 CAPSULE in 1 BOTTLE (71335-2004-8)	40 capsule	2022-02-10	0000-00-00	No	No	Current