Gabapentin

Product NDC
70934-636
11-digit product format
709340636
Labeler code
70934
Product ID
70934-636_ab0c9f34-c8ae-a268-e053-2995a90a271e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application
ANDA200651
Marketing category
ANDA
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
6CW7F3G59XGABAPENTIN60142-96-3GABAPENTIN

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-636-307093406363030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-636-30) 2020-03-300000-00-00NoNoCurrent
70934-636-907093406369090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-636-90) 2020-04-070000-00-00NoNoCurrent