FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
33358-420
11-digit product format
333580420
Labeler code
33358
Product ID
33358-420_94b44ddd-c19c-45d3-a779-be912f8380b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
RxChange Co.
Application
ANDA077903
Marketing category
ANDA
Marketing start
2014-11-20
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
E
Listing certified through
2017-12-31
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
33358-420-302020-01-31C16284748780-19d75b9d0-3a6f-f424-e053-dadaa90a57ceThese 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 C-IV Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33358-420-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33358-420-30EA - Each33358-4202af63172-81c0-497d-a6da-2e9a4848370f12015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [RXCHANGE CO.]1
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [RXCHANGE CO.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [RXCHANGE CO.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33358-420ZOLPIDEM TARTRATE TABLET [RXCHANGE CO.]1Legacy NDC, 1 package rows20141125_503b8e97-1fd1-4b29-a9b7-7fb87727fe4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN503b8e97-1fd1-4b29-a9b7-7fb87727fe4e1
854873zolpidem tartrate 10 MG Oral TabletSCD503b8e97-1fd1-4b29-a9b7-7fb87727fe4e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33358-420-303335804203030 in 1 BOTTLEHistorical