Gabapentin

Product NDC: 63187-231
Requested package NDC: 63187-231-78
11-digit product format: 631870231
Labeler code: 63187
Product ID: 63187-231_b5b3b2b0-9279-4b16-b1ae-b9388fcdf736
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA202764
Marketing category: ANDA
Marketing start: 2012-10-29
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 800 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63187-231	63187-231-78	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-231	63187-231-78	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-231	63187-231-78	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A202764-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL			2012-10-16
A202764-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL			2012-10-16

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 3 · 82 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	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202764-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2012-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202764-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2012-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202764-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2012-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202764-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2012-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202764-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2012-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202764-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2012-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202764-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2012-10-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202764-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2012-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202764-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2012-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202764-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2012-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202764-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2012-10-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202764-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2012-10-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202764-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202764-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202764-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202764-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202764-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202764-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202764-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202764-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202764-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202764-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202764-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202764-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202764-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202764-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202764-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202764-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202764-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202764-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202764-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202764-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202764-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202764-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202764-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202764-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202764-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202764-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202764-001	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202764-002	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202764-001	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202764-002	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202764-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202764-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202764-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202764-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202764-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202764-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202764-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202764-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202764-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202764-002	AB	1	`3f0d92c62455…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-231-60	EA - Each	63187-231	6bd550e3-e17b-49ce-a9dd-e1b3254ace6e	1	2016-09-02
63187-231-90	EA - Each	63187-231	27c5da3d-e85e-44dd-9c1e-fac0e721f21e	1	2016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET [PROFICIENT RX LP]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET [PROFICIENT RX LP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	GABAPENTIN TABLET [PROFICIENT RX LP]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	GABAPENTIN TABLET [PROFICIENT RX LP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN TABLET [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET [PROFICIENT RX LP]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GABAPENTIN TABLET [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	GABAPENTIN TABLET [PROFICIENT RX LP]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GABAPENTIN TABLET [PROFICIENT RX LP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN TABLET [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-231	GABAPENTIN TABLET [PROFICIENT RX LP]	3	Legacy NDC	20210121_71d84c83-b58b-44b6-a6fc-851f4f3b6c29.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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	Exelan Pharmaceuticals Inc.	323dad14-ded9-4432-a265-c957e46cc6db	2023-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202764 application number: ANDA202764
Gabapentin	GABAPENTIN	Cipla USA Inc.	7c3ac86f-b8f7-42bf-942a-db854d946e54	2023-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202764 application number: ANDA202764
Gabapentin	GABAPENTIN	Proficient Rx LP	f6baeb5c-ca9c-4730-aeb8-8f8732e8ca3a	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202764 application number: ANDA202764

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	Marketing end	Sample	Exclude flag	Status
63187-231-78	63187023178	180 TABLET in 1 BOTTLE (63187-231-78)	180 tablet	2018-12-01	0000-00-00	No	No	Current