FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
50436-0007
11-digit product format
504360007
Labeler code
50436
Product ID
50436-0007_9f16f3a0-f0db-4bb8-91a7-92349412d335
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
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
50436-0007-12021-01-29C16284748780-1ba0f9c33-1865-a910-e053-dadaa90a0b85These 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.
50436-0007-22021-01-29C16284748780-1ba0f9c33-1865-a910-e053-dadaa90a0b85These 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
50436-0007-1ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET308
50436-0007-2ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0007-1EA - Each50436-000792c09ed0-dbe6-4a83-8c61-648de2d950d212017-08-11
50436-0007-2EA - Each50436-000710fe2c7d-106c-439f-b761-6565bac2c56e12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0007ZOLPIDEM TARTRATE TABLET [UNIT DOSE SERVICES]8Legacy NDC, 2 package rows20170630_1211fbc0-7b2a-4bd0-8be4-9fdcc0553aee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN1211fbc0-7b2a-4bd0-8be4-9fdcc0553aee8
854876zolpidem tartrate 5 MG Oral TabletPSN1211fbc0-7b2a-4bd0-8be4-9fdcc0553aee8
854873zolpidem tartrate 10 MG Oral TabletSCD1211fbc0-7b2a-4bd0-8be4-9fdcc0553aee8
854876zolpidem tartrate 5 MG Oral TabletSCD1211fbc0-7b2a-4bd0-8be4-9fdcc0553aee8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0007-15043600070130 in 1 BOTTLEHistorical
50436-0007-25043600070260 in 1 BOTTLEHistorical