Zolpidem Tartrate

Product NDC
70518-3943
11-digit product format
705183943
Labeler code
70518
Product ID
70518-3943_3bb20a3a-6c53-a5bd-e063-6394a90a86c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078413
Marketing category
ANDA
Marketing start
2023-12-08
Substance
ZOLPIDEM TARTRATE
Active strength
10 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
WY6W63843KZOLPIDEM TARTRATE99294-93-6ZOLPIDEM TARTRATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3943-07051839430030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3943-0) 2023-12-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Zolpidem TartrateREMEDYREPACK INC.2025-08-06HUMAN PRESCRIPTION DRUG LABEL4