Gabapentin

Product NDC: 69292-642
Requested package NDC: 69292-642-10
11-digit product format: 692920642
Labeler code: 69292
Product ID: 69292-642_49d67ffb-5d4f-486e-8766-cf56faf70ede
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Amici Pharma, Inc.
Application: ANDA219319
Marketing category: ANDA
Marketing start: 2026-05-15
Substance: GABAPENTIN
Active strength: 400 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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A219319-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2025-08-07
A219319-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2025-08-07
A219319-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2025-08-07
A219319-004	GABAPENTIN	GABAPENTIN	200MG	CAPSULE / ORAL	AB	2026-05-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A219319-001	AB
A219319-002	AB
A219319-003	AB
A219319-004	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.

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	A219319-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2025-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219319-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2025-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219319-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2025-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219319-004	GABAPENTIN	200MG	CAPSULE / ORAL	AB	2026-05-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219319-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2025-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219319-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2025-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219319-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2025-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219319-004	GABAPENTIN	200MG	CAPSULE / ORAL	AB	2026-05-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219319-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2025-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219319-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2025-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219319-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2025-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219319-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2025-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219319-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2025-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219319-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2025-08-07	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219319-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2025-08-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219319-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2025-08-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219319-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2025-08-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219319-004	GABAPENTIN	200MG	CAPSULE / ORAL	AB	2026-05-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A219319-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219319-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219319-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219319-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219319-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219319-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219319-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219319-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219319-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219319-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219319-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219319-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219319-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219319-003	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219319-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219319-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219319-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219319-004	AB	1	`a50c72e98297…`

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: 2027-12-31

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 · 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
1ea83c18-7107-41f4-8305-62725c1c45c8	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
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
69292-642-01	Gabapentin	100 in 1 BOTTLE	CAPSULE	100	2
69292-642-10	Gabapentin	1000 in 1 BOTTLE	CAPSULE	1000	2
69292-642-50	Gabapentin	500 in 1 BOTTLE	CAPSULE	500	2

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	Pangea Pharmaceuticals, LLC	5eff7ad8-0d31-4372-82a2-ac9f549d8796	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219319 application number: ANDA219319
Gabapentin	GABAPENTIN	Amici Pharma, Inc.	1ea83c18-7107-41f4-8305-62725c1c45c8	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219319 application number: ANDA219319 ndc (package): 69292-642-10 ndc (product): 69292-642 ndc11 (package): 69292064210
GABAPENTIN	GABAPENTIN	STALLION LABORATORIES PRIVATE LIMITED	b26fd0c6-6aab-4957-8a32-cc7adb9b5fc9	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219319 application number: ANDA219319

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	1ea83c18-7107-41f4-8305-62725c1c45c8	2
310431	gabapentin 300 MG Oral Capsule	PSN	1ea83c18-7107-41f4-8305-62725c1c45c8	2
310432	gabapentin 400 MG Oral Capsule	PSN	1ea83c18-7107-41f4-8305-62725c1c45c8	2
310430	gabapentin 100 MG Oral Capsule	SCD	1ea83c18-7107-41f4-8305-62725c1c45c8	2
310431	gabapentin 300 MG Oral Capsule	SCD	1ea83c18-7107-41f4-8305-62725c1c45c8	2
310432	gabapentin 400 MG Oral Capsule	SCD	1ea83c18-7107-41f4-8305-62725c1c45c8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69292-642-10	69292064210	1000 CAPSULE in 1 BOTTLE (69292-642-10)	1000 capsule	2026-05-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Amici Pharma, Inc. \| Stallion laboratories Pvt. Ltd.	2026-05-19	HUMAN PRESCRIPTION DRUG LABEL	2