GABAPENTIN

Product NDC
68071-3445
11-digit product format
680713445
Labeler code
68071
Product ID
68071-3445_2d5a1af5-a987-2e15-e063-6294a90af9b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA214957
Marketing category
ANDA
Marketing start
2021-10-01
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3445-36807134450330 TABLET in 1 BOTTLE (68071-3445-3) 30 tablet2023-06-22NoNoHistorical
68071-3445-96807134450990 TABLET in 1 BOTTLE (68071-3445-9) 90 tablet2023-06-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GABAPENTINNuCare Pharmaceuticals,Inc. | NuCare Pharmaceuticals, Inc.2025-02-04HUMAN PRESCRIPTION DRUG LABEL3