FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
61919-955
11-digit product format
619190955
Labeler code
61919
Product ID
61919-955_bf1b22fc-d0f1-4204-a1f5-4302c0676616
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ZOLPIDEM TARTRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090107
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
13 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
61919-955-302020-01-31C16284748780-19d75b9cf-cfd7-f424-e053-dadaa90a57ceZOLPIDEM TARTRATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-955-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET, EXTENDED RELEASE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-955-30EA - Each61919-95531551864-33a3-4a8b-bd63-7cb12f64c37612015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
TALCINACTIVE INGREDIENT7SEV7J4R1UZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-955ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4Legacy NDC, 1 package rows20151113_84db101f-3194-4a40-83e3-403df03dffe1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN84db101f-3194-4a40-83e3-403df03dffe14
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD84db101f-3194-4a40-83e3-403df03dffe14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-955-306191909553030 in 1 BOTTLEHistorical