Pregabalin

Product NDC
70518-3974
11-digit product format
705183974
Labeler code
70518
Product ID
70518-3974_3bb4e62f-1283-ed43-e063-6394a90a46f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209743
Marketing category
ANDA
Marketing start
2024-01-03
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
70518-3974-07051839740030 CAPSULE in 1 BLISTER PACK (70518-3974-0) 30 capsule2024-01-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PregabalinREMEDYREPACK INC.2025-08-06HUMAN PRESCRIPTION DRUG LABEL7