FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
45865-409
11-digit product format
458650409
Labeler code
45865
Product ID
45865-409_72046304-31f0-9043-e053-2995a90a57ea
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
5 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
45865-409-302025-01-30C16284748780-12cef2736-71aa-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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
45865-409-602025-01-30C16284748780-12cef2736-71aa-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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-409-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET301
45865-409-60ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-409ZOLPIDEM TARTRATE TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20180728_72046304-31ef-9043-e053-2995a90a57ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSN72046304-31ef-9043-e053-2995a90a57ea1
854876zolpidem tartrate 5 MG Oral TabletSCD72046304-31ef-9043-e053-2995a90a57ea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-409-304586504093030 TABLET in 1 BOTTLE (45865-409-30) 30 tablet2018-01-010000-00-00NoNoCurrent
45865-409-604586504096060 TABLET in 1 BOTTLE (45865-409-60) 60 tablet2018-01-010000-00-00NoNoCurrent