Gabapentin

Product NDC: 60760-939
11-digit product format: 607600939
Labeler code: 60760
Product ID: 60760-939_56d33970-ae09-eb6c-e063-6394a90a348b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: St. Mary's Medical Park Pharmacy
Application: ANDA206943
Marketing category: ANDA
Marketing start: 2025-08-14
Substance: GABAPENTIN
Active strength: 100 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
A206943-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14
A206943-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14
A206943-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206943-001	AB
A206943-002	AB
A206943-003	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	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`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	A206943-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206943-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206943-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206943-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206943-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206943-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206943-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206943-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206943-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206943-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206943-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206943-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206943-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206943-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206943-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206943-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206943-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206943-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206943-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206943-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206943-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206943-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206943-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206943-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206943-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206943-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206943-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206943-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206943-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206943-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206943-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206943-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206943-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206943-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206943-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206943-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206943-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206943-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206943-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206943-001	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	100 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
310430	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
3c585b71-5cfc-18d6-e063-6294a90a3dcf	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	Strength	SPL version
60760-939-60	Gabapentin	60 in 1 BOTTLE, PLASTIC	CAPSULE	60		3
60760-939-90	Gabapentin	90 in 1 BOTTLE, PLASTIC	CAPSULE	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-939-60	EA - Each	60760-939	d6fe94e4-5584-4a1b-b578-cc607be172bd	1	2025-09-12
60760-939-90	EA - Each	60760-939	42b25e78-3ab3-4d42-8772-ebf355e8ed01	1	2026-03-17

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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	1ec656c9-034f-4f14-9e6b-9779d41e1627	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	8de89818-805a-4a20-a9b1-48cf443b6315	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	9efd0261-9fc9-4dc9-8cf3-9110157ddfc4	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	01b810b7-f4c8-4412-bbc5-b9220d8770d8	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	Medsource Pharmaceuticals	1278512b-1493-db65-e063-6394a90ab161	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	e286ed87-5fbc-4ff2-a05e-1f7fa658bbfc	2023-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	Proficient Rx LP	645824d0-eb3d-442b-806d-36a70796cb8e	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943

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	3c585b71-5cfc-18d6-e063-6294a90a3dcf	3
310430	gabapentin 100 MG Oral Capsule	SCD	3c585b71-5cfc-18d6-e063-6294a90a3dcf	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60760-939-60	60760093960	60 CAPSULE in 1 BOTTLE, PLASTIC (60760-939-60)	60 capsule	2025-08-14	No	No	Current
60760-939-90	60760093990	90 CAPSULE in 1 BOTTLE, PLASTIC (60760-939-90)	90 capsule	2026-02-04	No	No	Current