GABAPENTIN

Product NDC: 67046-1535
11-digit product format: 670461535
Labeler code: 67046
Product ID: 67046-1535_3133c7f0-e65d-ce80-e063-6294a90a8ae5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA214957
Marketing category: ANDA
Marketing start: 2025-03-25
Substance: GABAPENTIN
Active strength: 600 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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214957-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2021-10-01
A214957-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2021-10-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A214957-001	AB1
A214957-002	AB1

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 2 · 66 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
2026-02-19 14:30 UTC	2026-02	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2021-10-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2021-10-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2021-10-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2021-10-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2021-10-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2021-10-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2021-10-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2021-10-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2021-10-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2021-10-01	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214957-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214957-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214957-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214957-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214957-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214957-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214957-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214957-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214957-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214957-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214957-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214957-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214957-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214957-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214957-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214957-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214957-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214957-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214957-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214957-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214957-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214957-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214957-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214957-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214957-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214957-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214957-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214957-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214957-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214957-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214957-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214957-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214957-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214957-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214957-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214957-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214957-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214957-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214957-001	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214957-002	AB1	1	`6a51e52b5d6a…`

Additional Listing Data#

Finished product: Yes
Brand name base: GABAPENTIN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	600 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
310433	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
3133c863-d33b-c9d7-e063-6294a90ae898	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	Strength	SPL version
67046-1535-3	GABAPENTIN	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-1535	GABAPENTIN TABLET [COUPLER LLC]	1	Current NDC, 1 package rows	20250327_3133c863-d33b-c9d7-e063-6294a90ae898.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 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	c9f0cceb-b24e-4526-b873-fedd877d6bc6	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	St. Mary's Medical Park Pharmacy	07f07d15-ee91-8c2a-e063-6394a90a4624	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	180b99a5-7d3d-4ee5-a0cc-1ae0ede646ee	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	35da078b-0da0-4757-a6c4-a9144c37e8e1	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	38119f2e-33b3-4c3c-99b7-9335d8d280d4	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Coupler LLC	500ee820-0378-6fc9-e063-6394a90a109c	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	ST. MARY'S MEDICAL PARK PHARMACY	4ddc1342-5c83-f562-e063-6294a90a29ba	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	2e331641-ec26-4d76-b16b-a9863c767afe	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	60b46f6d-efbc-487a-b672-b20df8b44cc4	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Proficient Rx LP	da8438e1-755b-4195-baa7-464f3d9ee5bd	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Camber Pharmaceuticals, Inc.	9ead7825-d11b-4e00-8533-328d097b8f83	2025-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Exelan Pharmaceuticals, Inc.	a88edb00-2189-4c8d-9dd7-9fe1571775cc	2025-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	XLCare Pharmaceuticals, Inc.	707ed63a-67ca-4a62-9cbe-cdeb5c4ab506	2025-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
Gabapentin	GABAPENTIN	Direct_Rx	ed9c501c-24e4-da89-e053-2a95a90a64c6	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Asclemed USA, Inc.	1f1203f4-2184-4e13-e063-6394a90a4330	2025-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Proficient Rx LP	7fcce531-bf7c-43b6-bea9-8f0602842c53	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Coupler LLC	3133c863-d33b-c9d7-e063-6294a90ae898	2025-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957 ndc (product): 67046-1535
GABAPENTIN	GABAPENTIN	NuCare Pharmaceuticals,Inc.	febf610e-e088-4797-e053-6294a90a3eb5	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
Gabapentin	GABAPENTIN	Direct_Rx	fbc05ceb-2e69-3c37-e053-6394a90ac4f4	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Clinical Solutions Wholesale, LLC	934fefae-b895-427c-8798-4c5462b1ecc2	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957

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
310433	gabapentin 600 MG Oral Tablet	PSN	3133c863-d33b-c9d7-e063-6294a90ae898	1
310433	gabapentin 600 MG Oral Tablet	SCD	3133c863-d33b-c9d7-e063-6294a90ae898	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1535-3	67046153503	30 TABLET in 1 BLISTER PACK (67046-1535-3)	30 tablet	2025-03-25	No	No	Current