Zolpidem Tartrate

Product NDC
70518-1663
11-digit product format
705181663
Labeler code
70518
Product ID
70518-1663_e5bf6ea1-71f4-6fdb-e053-2995a90a6abc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076410
Marketing category
ANDA
Marketing start
2018-11-12
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
10 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1663-17051816630130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1663-1) 2020-03-090000-00-00NoNoCurrent
70518-1663-27051816630230 TABLET, FILM COATED in 1 BLISTER PACK (70518-1663-2) 2020-11-190000-00-00NoNoCurrent