FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
45865-413
11-digit product format
458650413
Labeler code
45865
Product ID
45865-413_1b65880c-3eac-4d7f-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
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
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
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
45865-413-302025-01-30C16284748780-12cef2736-766e-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets. Zolpidem tartrate tablets USP, for oral use, C-IV Initial U.S. Approval: 1992
45865-413-602025-01-30C16284748780-12cef2736-766e-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets. Zolpidem tartrate tablets USP, for oral use, C-IV Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-413-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET303
45865-413-60ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-413ZOLPIDEM TARTRATE TABLET [MEDSOURCE PHARMACEUTICALS]3Legacy NDC, 2 package rows20150827_1b66047b-4782-4808-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN1b66047b-4782-4808-e054-00144ff8d46c3
854873zolpidem tartrate 10 MG Oral TabletSCD1b66047b-4782-4808-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-413-304586504133030 TABLET in 1 BOTTLE (45865-413-30) 30 tablet2014-02-140000-00-00NoNoCurrent
45865-413-604586504136060 TABLET in 1 BOTTLE (45865-413-60) 60 tablet2014-02-140000-00-00NoNoCurrent