gabapentin

Product NDC
70518-4482
11-digit product format
705184482
Labeler code
70518
Product ID
70518-4482_3f62b056-9ce7-c339-e063-6394a90aecee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207099
Marketing category
ANDA
Marketing start
2025-09-19
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
70518-4482-07051844820090 CAPSULE in 1 BOTTLE, PLASTIC (70518-4482-0) 90 capsule2025-09-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
gabapentinREMEDYREPACK INC.2025-09-22HUMAN PRESCRIPTION DRUG LABEL1