Gabapentin

Product NDC
70518-4445
11-digit product format
705184445
Labeler code
70518
Product ID
70518-4445_3ca30e4b-efd0-f83c-e063-6394a90a2f95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
SOLUTION
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA216492
Marketing category
ANDA
Marketing start
2025-08-16
Substance
GABAPENTIN
Active strength
250 mg/5mL
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
70518-4445-07051844450010 CUP in 1 BOX (70518-4445-0) / 10 mL in 1 CUP (70518-4445-1) 10 cup2025-08-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GabapentinREMEDYREPACK INC.2025-08-18HUMAN PRESCRIPTION DRUG LABEL1