ZOLPIDEM TARTRATE

Product NDC
61919-348
11-digit product format
619190348
Labeler code
61919
Product ID
61919-348_e9ac6406-d211-e936-e053-2a95a90a0075
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ZOLPIDEM TARTRATE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
NDA021774
Marketing category
NDA
Marketing start
2017-10-31
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
13 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
61919-348-306191903483030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61919-348-30) 2022-09-270000-00-00NoNoCurrent