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 1 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	167d8b87-506c-4293-9579-563feaa71583	2026-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	3dac0d5f-6e65-4c58-9d2a-4f6910b2d4ef	2026-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	4615aaa7-73d4-4473-8f26-e7a982f8a166	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943 ndc (product): 70518-4740
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	57492b91-1fe2-74ab-e063-6394a90a0b9e	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	3c585b71-5cfc-18d6-e063-6294a90a3dcf	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	4ddcdff5-8f1f-bff3-e063-6294a90a1195	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	f93eaa4f-cc1a-10ab-e053-6394a90a5ffc	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	St Mary's Medical Park Pharmacy	de990f96-96bc-406d-e053-2995a90abebb	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals Inc.	6ecf5114-2ddc-4025-a36d-1884702dc22a	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals Inc.	f396ec70-826d-45c6-a27c-343c2fac878c	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	Strides Pharma Science Limited	798575b9-ddfa-4915-9574-626abbaf025f	2026-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ca8177ed-1f0d-436e-a5ac-f58b8f7cbb25	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	Direct_Rx	f40a4ee4-ae8e-769c-e053-2a95a90a344e	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	ADVANCED RX OF TENNESSEE, LLC	af73fbd8-9731-e6bf-e053-2995a90af65d	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	fb0b6613-57d6-4e24-946f-f5f87c460cf0	2024-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ef37f2a0-3b83-4f71-91c0-6435161b483c	2024-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	8e6ed5d2-40e0-1f06-e053-2a95a90aa40e	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	ed219efc-84e3-5bdc-e053-2a95a90a56fc	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	38210141-bbdc-4186-b71f-54c72f794dca	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	75418d32-6504-4cb4-b3a9-afa0eaf19b8d	2024-04-03	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