Gabapentin

Product NDC
0904-7108
11-digit product format
009047108
Labeler code
0904
Product ID
0904-7108_07b005ac-d21a-4ed4-a619-38bc75cdd139
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
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
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
6CW7F3G59XGABAPENTIN60142-96-3GABAPENTIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7108-6100904710861100 BLISTER PACK in 1 CARTON (0904-7108-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2011-10-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GabapentinMajor Pharmaceuticals2026-05-04HUMAN PRESCRIPTION DRUG LABEL8
GabapentinCardinal Health 107, LLC2025-12-05HUMAN PRESCRIPTION DRUG LABEL7