Zolpidem tartrate

Product NDC
49884-904
11-digit product format
498840904
Labeler code
49884
Product ID
49884-904_e8df627f-e5f9-4368-80a4-b0fdde64f134
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem tartrate
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA201509
Marketing category
ANDA
Marketing start
2016-11-04
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
10 mg/1
Pharmacologic classes
gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-904-524988409045210 TABLET in 1 BLISTER PACK (49884-904-52) 10 tablet2016-11-040000-00-00NoNoCurrent
49884-904-554988409045530 TABLET in 1 CARTON (49884-904-55) 30 tablet2016-11-040000-00-00NoNoCurrent