Gabapentin

Product NDC: 16571-117
11-digit product format: 165710117
Labeler code: 16571
Product ID: 16571-117_20c65bad-52d5-462e-aa17-5b7320f92b76
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA217995
Marketing category: ANDA
Marketing start: 2023-07-19
Substance: GABAPENTIN
Active strength: 800 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217995-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2023-07-19
A217995-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2023-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217995-001	AB1
A217995-002	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 · 42 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	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-07-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-07-19	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-07-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-07-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-07-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-07-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2023-07-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2023-07-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2023-07-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2023-07-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217995-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2023-07-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217995-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2023-07-19	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A217995-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217995-002	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217995-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217995-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217995-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217995-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217995-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217995-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217995-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217995-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217995-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217995-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217995-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217995-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217995-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217995-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217995-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217995-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217995-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217995-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217995-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217995-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217995-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217995-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217995-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217995-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217995-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217995-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217995-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217995-002	AB1	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217995-001	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217995-002	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217995-001	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217995-002	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217995-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217995-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217995-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217995-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217995-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217995-002	AB	1	`9b2671bbb829…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	800 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310433	Internal RxNorm lookup
310434	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
b1a9808d-31a5-4b63-afd0-d96d5a0ad7a1	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
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	Strength	SPL version
16571-117-01	Gabapentin	100 in 1 BOTTLE	TABLET	100		5
16571-117-50	Gabapentin	500 in 1 BOTTLE	TABLET	500		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-117-01	EA - Each	16571-117	c1cd5abd-b563-46fd-a647-e336728e63d8	1	2023-12-05
16571-117-50	EA - Each	16571-117	1de2fb14-8558-4d3d-a457-374979541554	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-117	GABAPENTIN TABLET [RISING PHARMA HOLDINGS, INC.]	2	Current NDC, 2 package rows	20240405_b1a9808d-31a5-4b63-afd0-d96d5a0ad7a1.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	cc1998a7-7004-4688-8b5b-525041851d1d	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217995 application number: ANDA217995
Gabapentin	GABAPENTIN	A-S Medication Solutions	6e900fc4-a2b3-411f-9ab7-8dcbb97b697b	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217995 application number: ANDA217995
Gabapentin	GABAPENTIN	A-S Medication Solutions	aa246838-609c-4254-a8ec-d6f463a17960	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217995 application number: ANDA217995
Gabapentin	GABAPENTIN	Rising Pharma Holdings, Inc.	b1a9808d-31a5-4b63-afd0-d96d5a0ad7a1	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217995 application number: ANDA217995 ndc (product): 16571-117
Gabapentin	GABAPENTIN	Rising Pharma Holdings, Inc.	8215da86-d7af-4980-b6d6-4bd46f6bfeaf	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217995 application number: ANDA217995

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	b1a9808d-31a5-4b63-afd0-d96d5a0ad7a1	5
310434	gabapentin 800 MG Oral Tablet	PSN	b1a9808d-31a5-4b63-afd0-d96d5a0ad7a1	5
310433	gabapentin 600 MG Oral Tablet	SCD	b1a9808d-31a5-4b63-afd0-d96d5a0ad7a1	5
310434	gabapentin 800 MG Oral Tablet	SCD	b1a9808d-31a5-4b63-afd0-d96d5a0ad7a1	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
16571-117-01	16571011701	100 TABLET in 1 BOTTLE (16571-117-01)	100 tablet	2023-07-19	No	No	Current
16571-117-50	16571011750	500 TABLET in 1 BOTTLE (16571-117-50)	500 tablet	2023-07-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Rising Pharma Holdings, Inc. \| Graviti Pharmaceuticals Private Limited	2025-09-03	HUMAN PRESCRIPTION DRUG LABEL	5