GABAPENTIN

Product NDC: 64380-869
Requested package NDC: 64380-869-06
11-digit product format: 643800869
Labeler code: 64380
Product ID: 64380-869_dcbeb06d-b93e-41c0-91e6-152e2ea6c32d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Strides Pharma Science Limited
Application: ANDA211314
Marketing category: ANDA
Marketing start: 2018-10-17
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 · 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 · 129 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	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A211314-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211314-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211314-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211314-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211314-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211314-003	AB	1	`caaa826d4ba7…`
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…`

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
43b67ae3-ac6f-48f5-8788-9ead08376864	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
64380-869-06	GABAPENTIN	100 in 1 BOTTLE	CAPSULE	100	10
64380-869-07	GABAPENTIN	500 in 1 BOTTLE	CAPSULE	500	10
64380-869-08	GABAPENTIN	1000 in 1 BOTTLE	CAPSULE	1000	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64380-869-06	EA - Each	64380-869	a3c775e5-85c4-415f-bd1e-58892dfcbf87	1	2019-10-07
64380-869-07	EA - Each	64380-869	995c9df4-dccc-46e2-9ce1-19c7f8f22ae5	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64380-869	GABAPENTIN CAPSULE [STRIDES PHARMA SCIENCE LIMITED]	7	Current NDC, Legacy NDC, 3 package rows	20250129_43b67ae3-ac6f-48f5-8788-9ead08376864.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	Bryant Ranch Prepack	4c22c3e6-2471-4b89-945b-f846c4d7884e	2026-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211314 application number: ANDA211314
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 ndc (package): 64380-869-06 ndc (product): 64380-869 ndc11 (package): 64380086906
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
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	43b67ae3-ac6f-48f5-8788-9ead08376864	10
310431	gabapentin 300 MG Oral Capsule	PSN	43b67ae3-ac6f-48f5-8788-9ead08376864	10
310432	gabapentin 400 MG Oral Capsule	PSN	43b67ae3-ac6f-48f5-8788-9ead08376864	10
310430	gabapentin 100 MG Oral Capsule	SCD	43b67ae3-ac6f-48f5-8788-9ead08376864	10
310431	gabapentin 300 MG Oral Capsule	SCD	43b67ae3-ac6f-48f5-8788-9ead08376864	10
310432	gabapentin 400 MG Oral Capsule	SCD	43b67ae3-ac6f-48f5-8788-9ead08376864	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64380-869-06	64380086906	100 CAPSULE in 1 BOTTLE (64380-869-06)	100 capsule	2018-10-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GABAPENTIN	Strides Pharma Science Limited \| Strides Pharma Global Pte. Ltd.	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	11