Zolpidem Tartrate

Product NDC
42291-964
11-digit product format
422910964
Labeler code
42291
Product ID
42291-964_d5ca211e-def6-d9aa-e053-2995a90a3570
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA076410
Marketing category
ANDA
Marketing start
2019-02-21
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
10 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-964-01EA - Each42291-9646d0e198d-b87d-43fc-96fe-d04d9856ea3812019-04-11
42291-964-10EA - Each42291-964067285a4-333d-4d15-92ae-ff2b5511960212019-04-11
42291-964-30EA - Each42291-9644a9c23cd-fe9c-4b0e-8fca-8f535a87494612020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-964ZOLPIDEM TARTRATE TABLET, FILM COATED [AVKARE]5Legacy NDC20240111_8247ff5c-c3da-f800-e053-2991aa0a9c48.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-964-0142291096401100 TABLET, FILM COATED in 1 BOTTLE (42291-964-01) 2019-02-210000-00-00NoNoCurrent
42291-964-10422910964101000 TABLET, FILM COATED in 1 BOTTLE (42291-964-10) 2019-02-210000-00-00NoNoCurrent
42291-964-304229109643030 TABLET, FILM COATED in 1 BOTTLE (42291-964-30) 2020-04-290000-00-00NoNoCurrent