ZOLPIDEM TARTRATE

Product NDC
61919-449
11-digit product format
619190449
Labeler code
61919
Product ID
61919-449_87d89d5e-19af-1a66-e053-2995a90a2f29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ZOLPIDEM TARTRATE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078179
Marketing category
ANDA
Marketing start
2018-03-15
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-449-30EA - Each61919-44988ba2360-3dc0-402b-9830-e8f645166aaf12018-04-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-449-306191904493030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61919-449-30) 2018-03-150000-00-00NoNoCurrent