Zolpidem Tartrate

Product NDC
71335-0079
11-digit product format
713350079
Labeler code
71335
Product ID
71335-0079_69ea837b-ed59-463a-90d4-e20de482709d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078179
Marketing category
ANDA
Marketing start
2010-10-14
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
6 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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0079-1EA - Each71335-00794fe14d4b-ead1-415a-be72-bdbb9f2128b712018-03-08
71335-0079-2EA - Each71335-0079c335a5cb-bd43-47ef-bac6-80a1690defd412018-03-08
71335-0079-3EA - Each71335-007909a8bcf2-194a-4cfa-90ff-c553619122cd12018-03-08
71335-0079-4EA - Each71335-0079d5cd8333-5c7f-476c-af8d-bb23b62e4a8612018-03-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0079-17133500790128 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0079-1) 2013-05-200000-00-00NoNoCurrent
71335-0079-27133500790230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0079-2) 2013-05-200000-00-00NoNoCurrent
71335-0079-37133500790360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0079-3) 2013-05-200000-00-00NoNoCurrent
71335-0079-4713350079048 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0079-4) 2013-05-200000-00-00NoNoCurrent