Zolpidem Tartrate

Product NDC
71335-0134
11-digit product format
713350134
Labeler code
71335
Product ID
71335-0134_347ec988-324f-47f7-9e18-149d586a85fd
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
2011-06-06
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
13 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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0134-1EA - Each71335-01346ce9654a-2383-4755-891e-b6bf4dbc50fd12018-03-08
71335-0134-2EA - Each71335-0134c5e8ac72-a987-4297-a311-dfa4ed7fbab312018-03-08
71335-0134-3EA - Each71335-01346ae1bcd6-7a57-445f-bc01-3bba7a03399912018-03-08
71335-0134-4EA - Each71335-0134333044b4-8398-4eef-8f20-8cc760616fff12018-03-08
71335-0134-5EA - Each71335-0134fba1231e-56e8-48bb-ba85-4c4a52486b6c12018-03-08
71335-0134-6EA - Each71335-0134415caee4-2192-4a5c-90ff-02dc0f5ba7f212018-03-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0134-17133501340130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0134-1) 2013-05-140000-00-00NoNoCurrent
71335-0134-27133501340260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0134-2) 2013-05-140000-00-00NoNoCurrent
71335-0134-37133501340328 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0134-3) 2013-05-140000-00-00NoNoCurrent
71335-0134-4713350134048 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0134-4) 2013-05-140000-00-00NoNoCurrent
71335-0134-57133501340518 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0134-5) 2013-05-140000-00-00NoNoCurrent
71335-0134-67133501340690 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0134-6) 2013-05-140000-00-00NoNoCurrent