Gabapentin

Product NDC
70518-4411
11-digit product format
705184411
Labeler code
70518
Product ID
70518-4411_3b24724a-e8bf-1031-e063-6394a90a703c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA206943
Marketing category
ANDA
Marketing start
2025-07-30
Substance
GABAPENTIN
Active strength
300 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
70518-4411-07051844110090 CAPSULE in 1 BOTTLE, PLASTIC (70518-4411-0) 90 capsule2025-07-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GabapentinREMEDYREPACK INC.2025-07-30HUMAN PRESCRIPTION DRUG LABEL2