Pregabalin

Product NDC
70518-4481
11-digit product format
705184481
Labeler code
70518
Product ID
70518-4481_3f018900-e477-28e8-e063-6294a90a1dab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207799
Marketing category
ANDA
Marketing start
2025-09-17
Substance
PREGABALIN
Active strength
25 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
55JG375S6MPREGABALIN148553-50-8PREGABALIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4481-07051844810090 CAPSULE in 1 BOTTLE, PLASTIC (70518-4481-0) 90 capsule2025-09-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PregabalinREMEDYREPACK INC.2025-09-17HUMAN PRESCRIPTION DRUG LABEL1