Gabapentin

Product NDC
71610-426
11-digit product format
716100426
Labeler code
71610
Product ID
71610-426_f44af22b-a99e-4c28-94af-f260bbb6ba0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA203244
Marketing category
ANDA
Marketing start
2014-01-11
Substance
GABAPENTIN
Active strength
800 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], 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
71610-426-607161004266090 TABLET, FILM COATED in 1 BOTTLE (71610-426-60) 2020-05-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GabapentinAphena Pharma Solutions - Tennessee, LLC2020-05-27HUMAN PRESCRIPTION DRUG LABEL1