gabapentin

Product NDC
67046-1591
11-digit product format
670461591
Labeler code
67046
Product ID
67046-1591_3eeda928-8d25-1afd-e063-6294a90a7901
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA207099
Marketing category
ANDA
Marketing start
2025-09-16
Substance
GABAPENTIN
Active strength
400 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
67046-1591-36704615910330 CAPSULE in 1 BLISTER PACK (67046-1591-3) 30 capsule2025-09-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
gabapentinCoupler LLC2025-09-16HUMAN PRESCRIPTION DRUG LABEL1