GABAPENTIN

Product NDC
67046-1535
11-digit product format
670461535
Labeler code
67046
Product ID
67046-1535_3133c7f0-e65d-ce80-e063-6294a90a8ae5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA214957
Marketing category
ANDA
Marketing start
2025-03-25
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
67046-1535-36704615350330 TABLET in 1 BLISTER PACK (67046-1535-3) 30 tablet2025-03-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GABAPENTINCoupler LLC2025-03-25HUMAN PRESCRIPTION DRUG LABEL1