Gabapentin

Product NDC: 60505-0112
Requested package NDC: 60505-0112-8
11-digit product format: 605050112
Labeler code: 60505
Product ID: 60505-0112_495d183d-f43e-cd94-750f-632891121be7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA075360
Marketing category: ANDA
Marketing start: 2005-04-06
Marketing end: 2022-02-28
Substance: GABAPENTIN
Active strength: 100 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60505-0112	60505-0112-8	D	Discontinued by firm		2026-08-03
excluded package	package	60505-0112	60505-0112-8	D	Discontinued by firm		2026-08-03

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 · 24 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 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A075360-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06
A075360-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06
A075360-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075360-001	AB
A075360-002	AB
A075360-003	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	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`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	A075360-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075360-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075360-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075360-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075360-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075360-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075360-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075360-001	AB	1	`8072bd15b7f6…`

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0112-0	EA - Each	60505-0112	c76f91c1-3c7e-4037-9b6b-707cd73809f1	1	2012-07-24
60505-0112-1	EA - Each	60505-0112	fb71dad1-307e-4487-bdec-f0ecd26fda43	1	2012-07-24
60505-0112-7	EA - Each	60505-0112	bdd90cd7-59ed-4c62-8cc5-bcb8340a5bf5	1	2012-07-24
60505-0112-8	EA - Each	60505-0112	90d04ed4-60c3-4e30-8b4b-be5261111a8c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.]	3
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	Granules Pharmaceuticals Inc	c681c804-c6f3-d63b-e053-2995a90a6b8f	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	397fd6d3-317b-4b61-a52b-3a09ca1d88a4	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	13640281-26b4-402e-8f69-7c81cd6e0376	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	ST. MARY'S MEDICAL PARK PHARMACY	3aaf3d6e-c6d5-89f5-e063-6394a90a9b77	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Granules Pharmaceuticals Inc.	b20ee34a-7f2d-4d62-a161-898565f74547	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	c859e666-d510-426b-e053-2995a90a9a3c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Asclemed USA, Inc.	5fb79774-c2d4-47ba-9a16-eb367d0fdcff	2023-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Proficient Rx LP	aa3ab216-372a-4a72-bfd1-88a1ffa31ba3	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Proficient Rx LP	185f264e-db32-41cd-b90d-519717b97850	2021-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360

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
310430	gabapentin 100 MG Oral Capsule	PSN	fd0d48d6-2cfb-4221-bedc-1b16121f4d05	2
310430	gabapentin 100 MG Oral Capsule	SCD	fd0d48d6-2cfb-4221-bedc-1b16121f4d05	2
310430	gabapentin 100 MG Oral Capsule	PSN	237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4	1
310431	gabapentin 300 MG Oral Capsule	PSN	237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4	1
310432	gabapentin 400 MG Oral Capsule	PSN	237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4	1
310430	gabapentin 100 MG Oral Capsule	SCD	237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4	1
310431	gabapentin 300 MG Oral Capsule	SCD	237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4	1
310432	gabapentin 400 MG Oral Capsule	SCD	237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0112-8	60505011208	1000 CAPSULE in 1 BOTTLE (60505-0112-8)	1000 capsule	2005-04-06	2022-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Apotex Corp. \| Apotex Inc.	2021-01-13	HUMAN PRESCRIPTION DRUG LABEL	14
Gabapentin	Carilion Materials Management	2016-06-16	HUMAN PRESCRIPTION DRUG LABEL	2
Gabapentin - Rebel Distributors Corp.	Rebel Distributors Corp.	2009-11-01	HUMAN PRESCRIPTION DRUG LABEL	1