Gabapentin

Product NDC: 70518-4740
11-digit product format: 705184740
Labeler code: 70518
Product ID: 70518-4740_5a06d51e-986e-44e7-e063-6394a90a959a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA206943
Marketing category: ANDA
Marketing start: 2026-08-27
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
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	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
4615aaa7-73d4-4473-8f26-e7a982f8a166	Available on FDA.report

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4740-0	70518474000	30 CAPSULE in 1 BLISTER PACK (70518-4740-0)	30 capsule	2026-08-27	No	No	Current