gabapentin

Product NDC: 50228-523
11-digit product format: 502280523
Labeler code: 50228
Product ID: 50228-523_3f2e32c6-5993-0189-e063-6294a90a0ff6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: ScieGen Pharmaceuticals, Inc.
Application: ANDA218491
Marketing category: ANDA
Marketing start: 2025-09-20
Substance: GABAPENTIN
Active strength: 300 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

openFDA Listing Details

Product ID: 50228-523_3f2e32c6-5993-0189-e063-6294a90a0ff6
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: gabapentin
Generic name: gabapentin
Dosage form: TABLET
Route: ORAL
Marketing start: 2025-09-20
Marketing category: ANDA
Application number: ANDA218491
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
Listing expiration: 2026-12-31

Ingredient	Strength
GABAPENTIN	300 mg/1

Field	Values
Unii	6CW7F3G59X
Rxcui	1806380, 1806382
Spl Set Id	3f2e3ac5-5233-fd57-e063-6294a90a849e
Manufacturer Name	ScieGen Pharmaceuticals, Inc.

UNII	Preferred term	Registry number	Matched term
6CW7F3G59X	GABAPENTIN	60142-96-3	GABAPENTIN

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50228-523-05	50228052305	500 TABLET in 1 BOTTLE (50228-523-05)	500 tablet	2025-09-20	No	No	Current
50228-523-30	50228052330	30 TABLET in 1 BOTTLE (50228-523-30)	30 tablet	2025-09-20	No	No	Current
50228-523-90	50228052390	90 TABLET in 1 BOTTLE (50228-523-90)	90 tablet	2025-09-20	No	No	Current

Title	Manufacturer	Effective date	Type	Version
gabapentin	ScieGen Pharmaceuticals, Inc.	2025-07-01	HUMAN PRESCRIPTION DRUG LABEL	1