FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
61919-527
11-digit product format
619190527
Labeler code
61919
Product ID
61919-527_ec8f5298-4530-44fe-9059-89b97cba1712
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ZOLPIDEM TARTRATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078616
Marketing category
ANDA
Marketing start
2014-01-01
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]
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
61919-527-102020-01-31C16284748780-19d75b9cf-fbae-f424-e053-dadaa90a57ceZOLPIDEM TARTRATE
61919-527-302020-01-31C16284748780-19d75b9cf-fbae-f424-e053-dadaa90a57ceZOLPIDEM TARTRATE
61919-527-602020-01-31C16284748780-19d75b9cf-fbae-f424-e053-dadaa90a57ceZOLPIDEM TARTRATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-527-10ZOLPIDEM TARTRATE10 in 1 BOTTLETABLET, FILM COATED104
61919-527-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET, FILM COATED304
61919-527-60ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-527-30EA - Each61919-527459349dd-7f17-4aad-9303-89f2e323c0d912015-03-03
61919-527-60EA - Each61919-527a78ffa0a-a854-4a04-872d-3baafc353b5112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4
TRIACETININACTIVE INGREDIENTXHX3C3X673ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-527ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4Legacy NDC, 3 package rows20151109_5baa7cf2-b6a6-4611-b4ad-7fe142220e2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN5baa7cf2-b6a6-4611-b4ad-7fe142220e2b4
854873zolpidem tartrate 10 MG Oral TabletSCD5baa7cf2-b6a6-4611-b4ad-7fe142220e2b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-527-106191905271010 in 1 BOTTLEHistorical
61919-527-306191905273030 in 1 BOTTLEHistorical
61919-527-606191905276060 in 1 BOTTLEHistorical