Gabapentin

Product NDC
68071-3783
11-digit product format
680713783
Labeler code
68071
Product ID
68071-3783_2c65033f-5eb1-27df-e063-6394a90a8c0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA207057
Marketing category
ANDA
Marketing start
2021-11-01
Substance
GABAPENTIN
Active strength
600 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 formatDescriptionMarketing startSampleExclude flagStatus
68071-3783-96807137830990 TABLET, COATED in 1 BOTTLE, PLASTIC (68071-3783-9) 2025-01-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GabapentinNuCare Pharmaceuticals, Inc.2025-01-23HUMAN PRESCRIPTION DRUG LABEL1