GABAPENTIN

Product NDC
70518-4493
11-digit product format
705184493
Labeler code
70518
Product ID
70518-4493_40a674f9-a64e-9c4e-e063-6394a90ac7ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA214956
Marketing category
ANDA
Marketing start
2025-10-08
Substance
GABAPENTIN
Active strength
100 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
70518-4493-070518449300100 CAPSULE in 1 BOTTLE, PLASTIC (70518-4493-0) 100 capsule2025-10-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GABAPENTINREMEDYREPACK INC.2025-10-08HUMAN PRESCRIPTION DRUG LABEL1