Gabapentin

Product NDC: 72162-2141
11-digit product format: 721622141
Labeler code: 72162
Product ID: 72162-2141_8b6e731b-e52c-4a2d-8fba-c994d9f015d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GABAPENTIN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA203244
Marketing category: ANDA
Marketing start: 2014-01-11
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 43.

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
A203244-001	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2013-07-12
A203244-002	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2013-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203244-001	AB1
A203244-002	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 3 · 86 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	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB	2013-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB	2013-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB	2013-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB	2013-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB	2013-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB	2013-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB	2013-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB	2013-07-12	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A203244-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203244-002	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203244-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203244-002	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203244-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203244-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203244-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203244-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203244-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203244-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203244-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203244-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203244-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203244-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203244-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203244-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203244-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203244-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203244-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203244-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203244-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203244-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203244-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203244-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203244-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203244-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203244-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203244-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203244-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203244-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203244-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203244-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203244-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203244-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203244-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203244-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203244-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203244-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203244-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203244-002	AB	1	`74a2ff9319b5…`

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: 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
0eb27e64-1488-4083-82c7-cebb8c0605de	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
72162-2141-1	Gabapentin	100 in 1 BOTTLE	TABLET, FILM COATED	100		101
72162-2141-5	Gabapentin	500 in 1 BOTTLE	TABLET, FILM COATED	500		101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-2141-5	EA - Each	72162-2141	4e06590a-ffc2-4947-a1a7-8a1420681eb1	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-2141	GABAPENTIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	101	Current NDC, 2 package rows	20231221_0eb27e64-1488-4083-82c7-cebb8c0605de.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	b6db5ce9-bd4b-420d-88a7-df9d46144c81	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Strides Pharma Science Limited	bec31452-b52b-4698-ba4c-0b614780ee84	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	7d3fc163-25f0-2c61-e053-2991aa0a76e9	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
GABAPENTIN	GABAPENTIN	DIRECT RX	a7e45e3f-e382-32ba-e053-2a95a90a2537	2025-01-17		Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	6e6b9d8f-9f9e-4760-96ea-fb8b0a3bbbdb	2024-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	47f2a06f-4eac-4dca-aa2a-a36dd4daaea0	2024-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	b4954172-5439-48fd-8348-8a2e0d2fee62	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	c9944562-563a-423d-972c-f0313375d234	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	56967a93-b3c0-4043-9241-585fc64e2624	2023-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	0eb27e64-1488-4083-82c7-cebb8c0605de	2023-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244 ndc (product): 72162-2141
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	39149f0e-30ed-4671-8be7-2a484f65d63b	2020-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Proficient Rx LP	8b2f38ef-0a0c-45cc-88ca-cc086bf80641	2020-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	ba2a8352-5776-4edb-914e-ce1d18ccda32	2020-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Proficient Rx LP	c09c66fd-cb31-41dd-b00b-acc58bd809f7	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244

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	0eb27e64-1488-4083-82c7-cebb8c0605de	101
310433	gabapentin 600 MG Oral Tablet	SCD	0eb27e64-1488-4083-82c7-cebb8c0605de	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72162-2141-1	72162214101	100 TABLET, FILM COATED in 1 BOTTLE (72162-2141-1)	2023-10-12	No	No	Current
72162-2141-5	72162214105	500 TABLET, FILM COATED in 1 BOTTLE (72162-2141-5)	2023-10-12	No	No	Current