Gabapentin

Product NDC
68071-5193
11-digit product format
680715193
Labeler code
68071
Product ID
68071-5193_263011b9-09a2-e225-e063-6394a90a3364
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090858
Marketing category
ANDA
Marketing start
2011-01-29
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
6CW7F3G59XGABAPENTIN60142-96-3GABAPENTIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-5193-36807151930330 CAPSULE in 1 BOTTLE (68071-5193-3) 30 capsule2020-03-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GabapentinNuCare Pharmaceuticals,Inc.2024-11-05HUMAN PRESCRIPTION DRUG LABEL4