Gabapentin

Product NDC: 71335-2381
Requested package NDC: 71335-2381-3
11-digit product format: 713352381
Labeler code: 71335
Product ID: 71335-2381_f02f4250-7d97-4dae-a9c2-f76e5d2f07c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA213603
Marketing category: ANDA
Marketing start: 2021-05-03
Substance: GABAPENTIN
Active strength: 400 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 43.

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
A213603-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17
A213603-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17
A213603-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213603-001	AB
A213603-002	AB
A213603-003	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 3 · 117 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
2026-09-14 22:38:34	2026-08	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213603-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213603-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213603-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213603-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213603-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213603-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213603-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213603-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213603-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213603-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213603-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213603-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213603-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213603-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213603-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213603-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Gabapentin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	400 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
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
ffe5321d-3405-46d5-a75f-c51e8f8d87b1	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
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	SPL version
71335-2381-1	Gabapentin	90 in 1 BOTTLE	CAPSULE	90	2
71335-2381-2	Gabapentin	28 in 1 BOTTLE	CAPSULE	28	2
71335-2381-3	Gabapentin	120 in 1 BOTTLE	CAPSULE	120	2
71335-2381-4	Gabapentin	30 in 1 BOTTLE	CAPSULE	30	2
71335-2381-5	Gabapentin	60 in 1 BOTTLE	CAPSULE	60	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-2381	GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]	2	Current NDC, 5 package rows	20250327_ffe5321d-3405-46d5-a75f-c51e8f8d87b1.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Zhejiang Yongtai Pharmaceutical Co., Ltd	f1eda6cc-d9b2-4df4-a09b-20eebded760f	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213603 application number: ANDA213603
Gabapentin	GABAPENTIN	Direct_Rx	e90d2e3d-ec86-7d1d-e053-2995a90a9167	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213603 application number: ANDA213603
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	2dad630a-09d8-4f40-bdad-24e877a9ee38	2024-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213603 application number: ANDA213603
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ffe5321d-3405-46d5-a75f-c51e8f8d87b1	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213603 application number: ANDA213603 ndc (package): 71335-2381-3 ndc (product): 71335-2381 ndc11 (package): 71335238103

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
310432	gabapentin 400 MG Oral Capsule	PSN	ffe5321d-3405-46d5-a75f-c51e8f8d87b1	2
310432	gabapentin 400 MG Oral Capsule	SCD	ffe5321d-3405-46d5-a75f-c51e8f8d87b1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2381-3	71335238103	120 CAPSULE in 1 BOTTLE (71335-2381-3)	120 capsule	2024-05-29	No	No	Current