Gabapentin

Product NDC
80425-0158
11-digit product format
804250158
Labeler code
80425
Product ID
80425-0158_2a99a7f4-89e9-19db-e063-6294a90a90da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA200651
Marketing category
ANDA
Marketing start
2011-10-06
Substance
GABAPENTIN
Active strength
800 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
80425-0158-18042501580130 TABLET, FILM COATED in 1 BOTTLE (80425-0158-1) 2011-10-06NoNoHistorical
80425-0158-28042501580260 TABLET, FILM COATED in 1 BOTTLE (80425-0158-2) 2011-10-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Gabapentin TabletsAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL6