FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
50090-4479
11-digit product format
500904479
Labeler code
50090
Product ID
50090-4479_88b7443d-97b5-4b6c-b090-be726b1597af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204170
Marketing category
ANDA
Marketing start
2017-05-15
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75543837-e611-4401-8337-81e7d5cb9b04Product name120231011
f40c5cae-52e4-45d3-95e3-8ba7f79e50e4Product name320201208
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
70793b8c-c4d9-ddb4-5f8a-4308eb0087a2Product name420171109
3970acdc-9e18-4f3d-165e-245802aafc57Product name220160829
438b1497-0992-6caa-062f-3853a7f9e4b1Product name120140508
813c8976-a1f1-3a35-1a71-1557bfb59446Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4479-02023-01-30C16284748780-1f386c64a-0b0a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS. ZOLPIDEM TARTRATE extended-release tablets, for oral use, C-IV Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4479-0Zolpidem Tartrate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4479ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20190831_4ac91321-0bf6-4f6b-99cf-472368f3e1c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN4ac91321-0bf6-4f6b-99cf-472368f3e1c01
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD4ac91321-0bf6-4f6b-99cf-472368f3e1c01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4479-05009044790030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4479-0) 2019-08-270000-00-00NoNoCurrent