Gabapentin

Product NDC: 67877-224
11-digit product format: 678770224
Labeler code: 67877
Product ID: 67877-224_4a89b23c-8061-4a4f-827e-62ec74d59be5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA090858
Marketing category: ANDA
Marketing start: 2011-01-29
Substance: GABAPENTIN
Active strength: 400 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A090858-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17
A090858-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17
A090858-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090858-001	AB
A090858-002	AB
A090858-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090858-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090858-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090858-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090858-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090858-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090858-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090858-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090858-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090858-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090858-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090858-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090858-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090858-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090858-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090858-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090858-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090858-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090858-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090858-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090858-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090858-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090858-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090858-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090858-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090858-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090858-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090858-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090858-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090858-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090858-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090858-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090858-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090858-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090858-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090858-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090858-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090858-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090858-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090858-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090858-001	AB	1	`1e350fbaab3a…`

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
722de2a9-38b3-4518-b262-ba0d1346d0ba	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
67877-224-01	Gabapentin	100 in 1 BOTTLE	CAPSULE	100	36
67877-224-05	Gabapentin	500 in 1 BOTTLE	CAPSULE	500	36
67877-224-10	Gabapentin	1000 in 1 BOTTLE	CAPSULE	1000	36
67877-224-38	Gabapentin	10 in 1 CARTON	CAPSULE	10	36
67877-224-38	Gabapentin	10 in 1 BLISTER PACK	CAPSULE	10	36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-224-01	EA - Each	67877-224	757fdadf-31e6-413b-b6fa-ac884d34c968	1	2012-07-24
67877-224-05	EA - Each	67877-224	38aa9f92-bd01-4690-9c1c-66abbb01eab8	1	2012-07-24
67877-224-10	EA - Each	67877-224	6b2433ab-7983-460d-bcb5-c75845a04103	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]	10
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]	10
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	GABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]	10
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]	10
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]	10
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]	10
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]	10
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-224	GABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]	36	Current NDC, Legacy NDC, 5 package rows	20250418_722de2a9-38b3-4518-b262-ba0d1346d0ba.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 2 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	ddb3a54f-5224-4024-8804-b2a2f01d885e	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	fce0c123-29d7-42bf-8c8d-8be1772e2d99	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	41844c21-9e2a-4332-a8ff-9b71ae9032b0	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	934244c6-243d-436e-ad6c-f7bd28e45a86	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Ascend Laboratories, LLC	722de2a9-38b3-4518-b262-ba0d1346d0ba	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858 ndc (product): 67877-224
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a1006139-7dfc-4d87-a5a9-aeb380c32d24	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	896c7782-1137-454b-aaa6-28f42c7413ef	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	6a0a75ac-e121-477b-a9d1-d11f588afc9d	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	7652adc6-1aad-4422-b85c-0c6b11c23b73	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	d06380d0-c894-427e-b13e-5a8f9eb86a34	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	78445dbf-c7cd-419f-a7be-72821e496628	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Major Pharmaceuticals	36f74fdf-0dae-47a0-a7ea-e64ac91cd88f	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	HAWAII REPACK, INC.	14d61caa-17ce-4fa2-90fb-1470f3864be8	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Northwind Health Company, LLC	552912b2-be59-0333-e063-6394a90a85c0	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Northwind Health Company, LLC	55292235-bf8f-46d0-e063-6294a90a91a5	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	3e633cd0-5ee8-4a05-bcfc-0a80209bf27f	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Unit Dose Solutions, Inc.	54ecc64b-f019-9fcb-e063-6294a90a00af	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	A-S Medication Solutions	03031adf-d36b-45ec-944e-dfce5a5de91a	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	d4f21e97-5e55-44c9-9b31-5f79ac2eb512	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Major Pharmaceuticals	999f3685-2eac-467e-bed2-1d0c36aaf0ed	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858

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
310432	gabapentin 400 MG Oral Capsule	PSN	f0e7a6c9-ae6c-4259-81ab-a37db54e3c80	105
310432	gabapentin 400 MG Oral Capsule	PSN	eb2f6784-e7be-41b6-871b-2c3c961664ab	105
310432	gabapentin 400 MG Oral Capsule	SCD	f0e7a6c9-ae6c-4259-81ab-a37db54e3c80	105
310432	gabapentin 400 MG Oral Capsule	SCD	eb2f6784-e7be-41b6-871b-2c3c961664ab	105
310430	gabapentin 100 MG Oral Capsule	PSN	03031adf-d36b-45ec-944e-dfce5a5de91a	44
310431	gabapentin 300 MG Oral Capsule	PSN	03031adf-d36b-45ec-944e-dfce5a5de91a	44
310432	gabapentin 400 MG Oral Capsule	PSN	03031adf-d36b-45ec-944e-dfce5a5de91a	44
310430	gabapentin 100 MG Oral Capsule	SCD	03031adf-d36b-45ec-944e-dfce5a5de91a	44
310431	gabapentin 300 MG Oral Capsule	SCD	03031adf-d36b-45ec-944e-dfce5a5de91a	44
310432	gabapentin 400 MG Oral Capsule	SCD	03031adf-d36b-45ec-944e-dfce5a5de91a	44
310430	gabapentin 100 MG Oral Capsule	PSN	722de2a9-38b3-4518-b262-ba0d1346d0ba	36
310431	gabapentin 300 MG Oral Capsule	PSN	722de2a9-38b3-4518-b262-ba0d1346d0ba	36
310432	gabapentin 400 MG Oral Capsule	PSN	722de2a9-38b3-4518-b262-ba0d1346d0ba	36
310430	gabapentin 100 MG Oral Capsule	SCD	722de2a9-38b3-4518-b262-ba0d1346d0ba	36
310431	gabapentin 300 MG Oral Capsule	SCD	722de2a9-38b3-4518-b262-ba0d1346d0ba	36
310432	gabapentin 400 MG Oral Capsule	SCD	722de2a9-38b3-4518-b262-ba0d1346d0ba	36
310432	gabapentin 400 MG Oral Capsule	PSN	78445dbf-c7cd-419f-a7be-72821e496628	19
310432	gabapentin 400 MG Oral Capsule	SCD	78445dbf-c7cd-419f-a7be-72821e496628	19
310431	gabapentin 300 MG Oral Capsule	PSN	517fdc6d-5e72-4ee6-8471-7a7f8f4ecfe7	13
310432	gabapentin 400 MG Oral Capsule	PSN	517fdc6d-5e72-4ee6-8471-7a7f8f4ecfe7	13
310431	gabapentin 300 MG Oral Capsule	SCD	517fdc6d-5e72-4ee6-8471-7a7f8f4ecfe7	13
310432	gabapentin 400 MG Oral Capsule	SCD	517fdc6d-5e72-4ee6-8471-7a7f8f4ecfe7	13
310430	gabapentin 100 MG Oral Capsule	PSN	36f74fdf-0dae-47a0-a7ea-e64ac91cd88f	10
310431	gabapentin 300 MG Oral Capsule	PSN	36f74fdf-0dae-47a0-a7ea-e64ac91cd88f	10
310432	gabapentin 400 MG Oral Capsule	PSN	36f74fdf-0dae-47a0-a7ea-e64ac91cd88f	10
310430	gabapentin 100 MG Oral Capsule	SCD	36f74fdf-0dae-47a0-a7ea-e64ac91cd88f	10
310431	gabapentin 300 MG Oral Capsule	SCD	36f74fdf-0dae-47a0-a7ea-e64ac91cd88f	10
310432	gabapentin 400 MG Oral Capsule	SCD	36f74fdf-0dae-47a0-a7ea-e64ac91cd88f	10
310432	gabapentin 400 MG Oral Capsule	PSN	0c51a5dd-b3d4-44f4-b674-fa434b1357dd	8
310432	gabapentin 400 MG Oral Capsule	SCD	0c51a5dd-b3d4-44f4-b674-fa434b1357dd	8
310430	gabapentin 100 MG Oral Capsule	PSN	bbfdedd7-2baf-4bc6-be59-548a5cf21752	7
310431	gabapentin 300 MG Oral Capsule	PSN	bbfdedd7-2baf-4bc6-be59-548a5cf21752	7
310432	gabapentin 400 MG Oral Capsule	PSN	bbfdedd7-2baf-4bc6-be59-548a5cf21752	7
310430	gabapentin 100 MG Oral Capsule	SCD	bbfdedd7-2baf-4bc6-be59-548a5cf21752	7
310431	gabapentin 300 MG Oral Capsule	SCD	bbfdedd7-2baf-4bc6-be59-548a5cf21752	7
310432	gabapentin 400 MG Oral Capsule	SCD	bbfdedd7-2baf-4bc6-be59-548a5cf21752	7
310432	gabapentin 400 MG Oral Capsule	PSN	c89a68b6-6dc0-4624-e053-2a95a90a687e	5
310432	gabapentin 400 MG Oral Capsule	SCD	c89a68b6-6dc0-4624-e053-2a95a90a687e	5
310430	gabapentin 100 MG Oral Capsule	PSN	59a01ec3-97d4-c099-e053-2a91aa0af754	2
310431	gabapentin 300 MG Oral Capsule	PSN	59a01ec3-97d4-c099-e053-2a91aa0af754	2
310431	gabapentin 300 MG Oral Capsule	PSN	14b1840d-a2db-4eec-bc25-029e35b042e4	2
310432	gabapentin 400 MG Oral Capsule	PSN	59a01ec3-97d4-c099-e053-2a91aa0af754	2
310432	gabapentin 400 MG Oral Capsule	PSN	176c5b60-93c2-4574-8b51-c15180912aaa	2
310432	gabapentin 400 MG Oral Capsule	PSN	14b1840d-a2db-4eec-bc25-029e35b042e4	2
310430	gabapentin 100 MG Oral Capsule	SCD	59a01ec3-97d4-c099-e053-2a91aa0af754	2
310431	gabapentin 300 MG Oral Capsule	SCD	14b1840d-a2db-4eec-bc25-029e35b042e4	2
310431	gabapentin 300 MG Oral Capsule	SCD	59a01ec3-97d4-c099-e053-2a91aa0af754	2
310432	gabapentin 400 MG Oral Capsule	SCD	14b1840d-a2db-4eec-bc25-029e35b042e4	2
310432	gabapentin 400 MG Oral Capsule	SCD	176c5b60-93c2-4574-8b51-c15180912aaa	2
310432	gabapentin 400 MG Oral Capsule	SCD	59a01ec3-97d4-c099-e053-2a91aa0af754	2
310432	gabapentin 400 MG Oral Capsule	PSN	743faa18-5e7c-4fcc-9781-4157450d90c4	1
310432	gabapentin 400 MG Oral Capsule	PSN	04a0c58c-dddf-462d-96e6-9317161ea496	1
310432	gabapentin 400 MG Oral Capsule	PSN	6fc8e8b2-5d0e-4c72-9a46-6d312c3efac7	1
310432	gabapentin 400 MG Oral Capsule	SCD	743faa18-5e7c-4fcc-9781-4157450d90c4	1
310432	gabapentin 400 MG Oral Capsule	SCD	6fc8e8b2-5d0e-4c72-9a46-6d312c3efac7	1
310432	gabapentin 400 MG Oral Capsule	SCD	04a0c58c-dddf-462d-96e6-9317161ea496	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-224-01	67877022401	100 CAPSULE in 1 BOTTLE (67877-224-01)	100 capsule	2011-01-29	0000-00-00	No	No	Current
67877-224-05	67877022405	500 CAPSULE in 1 BOTTLE (67877-224-05)	500 capsule	2011-01-29	0000-00-00	No	No	Current
67877-224-10	67877022410	1000 CAPSULE in 1 BOTTLE (67877-224-10)	1000 capsule	2011-01-29	0000-00-00	No	No	Current
67877-224-38	67877022438	10 BLISTER PACK in 1 CARTON (67877-224-38) / 10 CAPSULE in 1 BLISTER PACK	10 blister pack	2020-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Bryant Ranch Prepack	2026-08-19	HUMAN PRESCRIPTION DRUG LABEL	106
Gabapentin	Bryant Ranch Prepack	2026-08-19	HUMAN PRESCRIPTION DRUG LABEL	106
Gabapentin	Ascend Laboratories, LLC \| Alkem Laboratories Limited	2026-07-24	Human Prescription Drug Label	39
Gabapentin	REMEDYREPACK INC.	2026-07-15	HUMAN PRESCRIPTION DRUG LABEL	21
Gabapentin	REMEDYREPACK INC.	2026-07-06	HUMAN PRESCRIPTION DRUG LABEL	20
Gabapentin	Major Pharmaceuticals	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	11
Gabapentin	HAWAII REPACK, INC.	2026-06-26	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin	A-S Medication Solutions	2026-05-28	Human Prescription Drug Label	44
Gabapentin	American Health Packaging	2025-10-03	HUMAN PRESCRIPTION DRUG LABEL	7
Gabapentin	Preferred Pharmaceuticals, Inc.	2025-06-06	HUMAN PRESCRIPTION DRUG LABEL	12
Gabapentin	Preferred Pharmaceuticals Inc.	2025-06-06	HUMAN PRESCRIPTION DRUG LABEL	7
Gabapentin	Clinical Solutions Wholesale, LLC	2025-01-16	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin Capsule	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	5
Gabapentin	Quality Care Products, LLC	2024-12-18	Human Prescription Drug Label	8
Gabapentin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-06	HUMAN PRESCRIPTION DRUG LABEL	2
Gabapentin	Unit Dose Services	2022-11-16	Human Prescription Drug Label	13
Gabapentin	Proficient Rx LP	2022-08-01	HUMAN PRESCRIPTION DRUG LABEL	2
Gabapentin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-07-09	HUMAN PRESCRIPTION DRUG LABEL	2