GABAPENTIN

Product NDC: 23155-867
11-digit product format: 231550867
Labeler code: 23155
Product ID: 23155-867_5cc5ceff-77b9-40d2-bba6-0d4af992e3f8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application: ANDA211314
Marketing category: ANDA
Marketing start: 2023-06-25
Marketing end: 2026-11-30
Substance: GABAPENTIN
Active strength: 300 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	23155-867	23155-867-10	D	Discontinued by firm		2026-08-11

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
A211314-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16
A211314-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16
A211314-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211314-001	AB
A211314-002	AB
A211314-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211314-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211314-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211314-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211314-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211314-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211314-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211314-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211314-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211314-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211314-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211314-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211314-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211314-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211314-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211314-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211314-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211314-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211314-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211314-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211314-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211314-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211314-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211314-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211314-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211314-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211314-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211314-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211314-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211314-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211314-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211314-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211314-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211314-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211314-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211314-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211314-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211314-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211314-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211314-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211314-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: GABAPENTIN

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 · 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
d8daa30f-1cb3-46aa-9b68-d9aa5b0a2105	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	SPL version
23155-867-01	GABAPENTIN	100 in 1 BOTTLE	CAPSULE	100	7
23155-867-05	GABAPENTIN	500 in 1 BOTTLE	CAPSULE	500	7
23155-867-10	GABAPENTIN	1000 in 1 BOTTLE	CAPSULE	1000	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
23155-867-01	EA - Each	23155-867	455f8004-e674-4b47-b908-a835e1051f59	1	2023-12-05
23155-867-05	EA - Each	23155-867	3a7dcb71-856d-42a6-9b5b-1b58a2d4b5f9	1	2023-12-05
23155-867-10	EA - Each	23155-867	869ba8d7-4b84-4acc-9dae-f2e3f9e6fdf9	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
23155-867	GABAPENTIN CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]	5	Current NDC, 3 package rows	20250529_d8daa30f-1cb3-46aa-9b68-d9aa5b0a2105.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	Strides Pharma Science Limited	43b67ae3-ac6f-48f5-8788-9ead08376864	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211314 application number: ANDA211314
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	4c22c3e6-2471-4b89-945b-f846c4d7884e	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211314 application number: ANDA211314
GABAPENTIN	GABAPENTIN	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	d8daa30f-1cb3-46aa-9b68-d9aa5b0a2105	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211314 application number: ANDA211314 ndc (product): 23155-867
GABAPENTIN	GABAPENTIN	Coupler LLC	2cdbb381-88a2-5c5a-e063-6294a90a3e1e	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211314 application number: ANDA211314

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	d8daa30f-1cb3-46aa-9b68-d9aa5b0a2105	7
310431	gabapentin 300 MG Oral Capsule	PSN	d8daa30f-1cb3-46aa-9b68-d9aa5b0a2105	7
310432	gabapentin 400 MG Oral Capsule	PSN	d8daa30f-1cb3-46aa-9b68-d9aa5b0a2105	7
310430	gabapentin 100 MG Oral Capsule	SCD	d8daa30f-1cb3-46aa-9b68-d9aa5b0a2105	7
310431	gabapentin 300 MG Oral Capsule	SCD	d8daa30f-1cb3-46aa-9b68-d9aa5b0a2105	7
310432	gabapentin 400 MG Oral Capsule	SCD	d8daa30f-1cb3-46aa-9b68-d9aa5b0a2105	7
310431	gabapentin 300 MG Oral Capsule	PSN	2cdbb381-88a2-5c5a-e063-6294a90a3e1e	1
310431	gabapentin 300 MG Oral Capsule	SCD	2cdbb381-88a2-5c5a-e063-6294a90a3e1e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
23155-867-01	23155086701	100 CAPSULE in 1 BOTTLE (23155-867-01)	100 capsule	2023-06-25	2026-11-30	No	No	Historical
23155-867-05	23155086705	500 CAPSULE in 1 BOTTLE (23155-867-05)	500 capsule	2023-06-25	2026-11-30	No	No	Historical
23155-867-10	23155086710	1000 in 1 BOTTLE						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GABAPENTIN	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. \| Strides Pharma Global Pte. Ltd. \| Strides Pharma Science Limited	2026-02-12	HUMAN PRESCRIPTION DRUG LABEL	7
GABAPENTIN	Coupler LLC \| Strides Pharma Global Pte. Ltd.	2025-01-29	HUMAN PRESCRIPTION DRUG LABEL	1