Gabapentin

Product NDC: 45963-557
Requested package NDC: 45963-557-77
11-digit product format: 459630557
Labeler code: 45963
Product ID: 45963-557_63f9a25b-d34f-4b4b-8ccd-e0f6dac569f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA075350
Marketing category: ANDA
Marketing start: 2014-04-03
Substance: GABAPENTIN
Active strength: 400 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

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
unfinished package	package	45963-557	45963-557-77	UNFINISHED	Active or certified unfinished drug listing		2026-08-12

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 · 14 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075350-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12
A075350-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12
A075350-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075350-001	AB
A075350-002	AB
A075350-003	AB

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 4 · 123 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	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A075350-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075350-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075350-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075350-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075350-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075350-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075350-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075350-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075350-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075350-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075350-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075350-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075350-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075350-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075350-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075350-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075350-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075350-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075350-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075350-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075350-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075350-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075350-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075350-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075350-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075350-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075350-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075350-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075350-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075350-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075350-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075350-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075350-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075350-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075350-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075350-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075350-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075350-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075350-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075350-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	400 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310430	Internal RxNorm lookup
310431	Internal RxNorm lookup
310432	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
5969871e-6c71-4c37-9d63-370718ccc80c	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
45963-557-11	Gabapentin	100 in 1 BOTTLE	CAPSULE	100		23
45963-557-50	Gabapentin	500 in 1 BOTTLE	CAPSULE	500		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45963-557-11	EA - Each	45963-557	6ca654ca-d9e1-4994-b817-2efbe4ce29f2	1	2014-06-03
45963-557-50	EA - Each	45963-557	9dc85547-5f8f-47a3-b49f-8884c499c28b	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	7
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	7
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	7
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	7
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GABAPENTIN CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GABAPENTIN CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	GABAPENTIN CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	GABAPENTIN CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GABAPENTIN CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABAPENTIN CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GABAPENTIN CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [AMERICAN HEALTH PACKAGING]	2
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [AMERICAN HEALTH PACKAGING]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GABAPENTIN CAPSULE [AMERICAN HEALTH PACKAGING]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GABAPENTIN CAPSULE [AMERICAN HEALTH PACKAGING]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	GABAPENTIN CAPSULE [AMERICAN HEALTH PACKAGING]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	GABAPENTIN CAPSULE [AMERICAN HEALTH PACKAGING]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN CAPSULE [AMERICAN HEALTH PACKAGING]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [AMERICAN HEALTH PACKAGING]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE [AMERICAN HEALTH PACKAGING]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [AMERICAN HEALTH PACKAGING]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GABAPENTIN CAPSULE [AMERICAN HEALTH PACKAGING]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABAPENTIN CAPSULE [AMERICAN HEALTH PACKAGING]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE [AMERICAN HEALTH PACKAGING]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GABAPENTIN CAPSULE [AMERICAN HEALTH PACKAGING]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [AMERICAN HEALTH PACKAGING]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [AMERICAN HEALTH PACKAGING]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN CAPSULE [AMERICAN HEALTH PACKAGING]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [AMERICAN HEALTH PACKAGING]	2
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [DIRECT RX]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [DIRECT RX]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GABAPENTIN CAPSULE [DIRECT RX]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GABAPENTIN CAPSULE [DIRECT RX]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	GABAPENTIN CAPSULE [DIRECT RX]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	GABAPENTIN CAPSULE [DIRECT RX]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN CAPSULE [DIRECT RX]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [DIRECT RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [DIRECT RX]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GABAPENTIN CAPSULE [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABAPENTIN CAPSULE [DIRECT RX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GABAPENTIN CAPSULE [DIRECT RX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [DIRECT RX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN CAPSULE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45963-557	GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]	19	Current NDC, Legacy NDC, 2 package rows	20250119_5969871e-6c71-4c37-9d63-370718ccc80c.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Teva Pharmaceuticals, Inc.	c7f21eaa-68ee-420c-9c98-e997cc73a297	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	b4c7388a-19d9-4e3a-83c9-4943fb855be4	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Actavis Pharma, Inc.	5969871e-6c71-4c37-9d63-370718ccc80c	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350 ndc (product): 45963-557
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	afc80b8b-da39-6fb9-e053-2a95a90a2d8e	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	77754734-4125-42b1-97c8-458bcab2bcf1	2024-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Proficient Rx LP	c7cb37f9-e1df-4e2a-bde5-9bfa0e040d7a	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Asclemed USA, Inc.	e89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc8	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Proficient Rx LP	f651a143-3f88-49c9-b5c4-c9af55aea76a	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	37d4d465-19a5-46db-80dc-0b7334b3343a	2018-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	86b30e64-fe56-42b3-a0f8-d9ef5d4b8c49	2016-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350

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
310432	gabapentin 400 MG Oral Capsule	PSN	130f4b5b-eefe-4ce6-8555-c872a8082c17	26
310432	gabapentin 400 MG Oral Capsule	SCD	130f4b5b-eefe-4ce6-8555-c872a8082c17	26
310430	gabapentin 100 MG Oral Capsule	PSN	5969871e-6c71-4c37-9d63-370718ccc80c	23
310431	gabapentin 300 MG Oral Capsule	PSN	5969871e-6c71-4c37-9d63-370718ccc80c	23
310432	gabapentin 400 MG Oral Capsule	PSN	5969871e-6c71-4c37-9d63-370718ccc80c	23
310430	gabapentin 100 MG Oral Capsule	SCD	5969871e-6c71-4c37-9d63-370718ccc80c	23
310431	gabapentin 300 MG Oral Capsule	SCD	5969871e-6c71-4c37-9d63-370718ccc80c	23
310432	gabapentin 400 MG Oral Capsule	SCD	5969871e-6c71-4c37-9d63-370718ccc80c	23
310432	gabapentin 400 MG Oral Capsule	PSN	77754734-4125-42b1-97c8-458bcab2bcf1	21
310432	gabapentin 400 MG Oral Capsule	SCD	77754734-4125-42b1-97c8-458bcab2bcf1	21
310432	gabapentin 400 MG Oral Capsule	PSN	c7cb37f9-e1df-4e2a-bde5-9bfa0e040d7a	5
310432	gabapentin 400 MG Oral Capsule	PSN	f08849b1-a914-4e94-bbce-ebd72e785986	5
310432	gabapentin 400 MG Oral Capsule	SCD	c7cb37f9-e1df-4e2a-bde5-9bfa0e040d7a	5
310432	gabapentin 400 MG Oral Capsule	SCD	f08849b1-a914-4e94-bbce-ebd72e785986	5
310432	gabapentin 400 MG Oral Capsule	PSN	74f888ce-5f84-cad0-e053-2991aa0a2d79	2
310432	gabapentin 400 MG Oral Capsule	SCD	74f888ce-5f84-cad0-e053-2991aa0a2d79	2
310431	gabapentin 300 MG Oral Capsule	PSN	86b30e64-fe56-42b3-a0f8-d9ef5d4b8c49	1
310432	gabapentin 400 MG Oral Capsule	PSN	86b30e64-fe56-42b3-a0f8-d9ef5d4b8c49	1
310431	gabapentin 300 MG Oral Capsule	SCD	86b30e64-fe56-42b3-a0f8-d9ef5d4b8c49	1
310432	gabapentin 400 MG Oral Capsule	SCD	86b30e64-fe56-42b3-a0f8-d9ef5d4b8c49	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
45963-557-77	45963055777	15930 CAPSULE in 1 CONTAINER (45963-557-77)	15930 capsule	18-JAN-24	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Actavis Pharma, Inc.	2025-05-01	HUMAN PRESCRIPTION DRUG LABEL	24
Gabapentin	Bryant Ranch Prepack	2024-10-23	HUMAN PRESCRIPTION DRUG LABEL	21
Gabapentin	Proficient Rx LP	2022-11-01	HUMAN PRESCRIPTION DRUG LABEL	5
Gabapentin	Bryant Ranch Prepack	2022-02-21	HUMAN PRESCRIPTION DRUG LABEL	26
Gabapentin	American Health Packaging	2020-12-04	HUMAN PRESCRIPTION DRUG LABEL	7
Gabapentin	Preferred Pharmaceuticals, Inc.	2020-06-02	HUMAN PRESCRIPTION DRUG LABEL	2
GABAPENTIN	Direct_Rx	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
Gabapentin	Preferred Pharmaceuticals, Inc.	2019-12-27	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2018-12-20	HUMAN PRESCRIPTION DRUG LABEL	2
Gabapentin	St. Mary's Medical Park Pharmacy	2018-11-13	HUMAN PRESCRIPTION DRUG LABEL	3
Gabapentin	NuCare Pharmaceuticals,Inc.	2018-02-19	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin	Aphena Pharma Solutions - Tennessee, LLC	2016-06-20	HUMAN PRESCRIPTION DRUG LABEL	1
GABAPENTIN	DIRECT RX	2016-05-31	HUMAN PRESCRIPTION DRUG LABEL	5
GABAPENTIN CAPSULES, USP	NCS HealthCare of KY, Inc dba Vangard Labs	2015-01-26	HUMAN PRESCRIPTION DRUG LABEL	5