Gabapentin

Product NDC: 63629-8489
Requested package NDC: 63629-8489-1
11-digit product format: 636298489
Labeler code: 63629
Product ID: 63629-8489_b47bf116-e923-416d-b98a-281dde7ea05d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA205101
Marketing category: ANDA
Marketing start: 2016-02-04
Substance: GABAPENTIN
Active strength: 800 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A205101-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2016-02-04
A205101-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2016-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205101-001	AB1
A205101-002	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 · 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	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2016-02-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2016-02-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2016-02-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2016-02-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2016-02-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2016-02-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2016-02-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2016-02-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2016-02-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2016-02-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2016-02-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2016-02-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A205101-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205101-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205101-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205101-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205101-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205101-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205101-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205101-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205101-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205101-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205101-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205101-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205101-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205101-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205101-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205101-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205101-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205101-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205101-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205101-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205101-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205101-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205101-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205101-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205101-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205101-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205101-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205101-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205101-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205101-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205101-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205101-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205101-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205101-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205101-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205101-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205101-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205101-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205101-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205101-002	AB	1	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	9b175f8d-7667-4bfe-8bb5-fd7441eed456	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	HAWAII REPACK, INC.	f6ff265b-569b-4f5c-8fdb-00b7ad4aac7c	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	ba4d863d-be38-8cf5-e053-2995a90a69fb	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	c85ae572-9893-629e-e053-2995a90a23fc	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ce0f0d7f-da6d-47da-a4ed-fb8f72902412	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	abb56036-88df-4720-ba78-529971671545	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a75c9157-a1fc-44cc-89f8-c5a3742fb9ed	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101 ndc (package): 63629-8489-1 ndc (product): 63629-8489 ndc11 (package): 63629848901
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	d1aa4690-57b5-4a3e-ac12-85f777dbd05e	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	75caca13-1432-4c0d-8d45-f029b0b2d417	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	56378630-e7a7-4981-8212-8ea703a433d8	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Radha Pharmaceuticals, Inc.	1045db4e-4c76-4a0d-bf12-019bd96a8f59	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	ScieGen Pharmaceuticals, Inc.	5ab9c18b-9568-4dcb-90b0-252aef8f8dc2	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals, Inc.	5d3f27bf-3486-40fa-a4d3-5f0b2c6c0151	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals, Inc.	561f53d5-5301-42b3-b372-f3d49d642a2e	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Coupler LLC	3133fc78-dd7a-880c-e063-6394a90a89e1	2025-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Directrx	d5c9dd2c-b8ee-1406-e053-2995a90a0287	2025-01-21	Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
GABAPENTIN	GABAPENTIN	DIRECT RX	a7e45e3f-e382-32ba-e053-2a95a90a2537	2025-01-17		Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Creekwood Pharmaceuticals LLC	266ef369-0a56-f225-e063-6294a90a495e	2024-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	a9c99dfa-f54d-9207-e053-2995a90ad43b	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	a9f0852e-0c58-ba22-e053-2995a90adfa0	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101

Additional Listing Data#

Finished product: Yes
Brand name base: Gabapentin
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
a75c9157-a1fc-44cc-89f8-c5a3742fb9ed	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
63629-8489-1	Gabapentin	500 in 1 BOTTLE	TABLET	500		105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8489-1	EA - Each	63629-8489	29aaef5e-95a2-48c3-9c30-777b3ebf8c73	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8489	GABAPENTIN TABLET [BRYANT RANCH PREPACK]	104	Current NDC, Legacy NDC, 1 package rows	20241220_a75c9157-a1fc-44cc-89f8-c5a3742fb9ed.zip

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
310434	gabapentin 800 MG Oral Tablet	PSN	a75c9157-a1fc-44cc-89f8-c5a3742fb9ed	105
310434	gabapentin 800 MG Oral Tablet	SCD	a75c9157-a1fc-44cc-89f8-c5a3742fb9ed	105

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8489-1	63629848901	500 TABLET in 1 BOTTLE (63629-8489-1)	500 tablet	2016-02-04	0000-00-00	No	No	Current