Zolpidem Tartrate

Product NDC
63739-526
11-digit product format
637390526
Labeler code
63739
Product ID
63739-526_c19a2d17-4509-d821-e053-2995a90aed7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA078413
Marketing category
ANDA
Marketing start
2007-05-04
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-526-102020-07-22C16284748780-1ab0e2407-292c-f274-e053-dbdaa90a64711cfe5171-26bf-4a93-8bd8-2b252c1a16ad

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-526-10EA - Each63739-526253ed8cf-ef19-45a4-a0d9-a8c7a797fdf212012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-526-106373905261010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-526-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2007-05-040000-00-00NoNoCurrent