Zolpidem Tartrate

Product NDC
66336-718
11-digit product format
663360718
Labeler code
66336
Product ID
66336-718_e0d2aa04-ee64-4806-9ef0-7a79cd869aa7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA078616
Marketing category
ANDA
Marketing start
2008-11-21
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
66336-718-152019-11-27C16284748780-19855d018-d5e6-cd31-e053-dbdaa90ab51aThese 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, for oral use CIV Initial U.S. Approval: 1992
66336-718-102019-11-13C16284748780-197449f38-b9ed-f6ea-e053-dbdaa90aa703These 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 CIV Initial U.S. Approval: 1992
66336-718-302019-11-13C16284748780-197449f38-b9ed-f6ea-e053-dbdaa90aa703These 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 CIV Initial U.S. Approval: 1992
66336-718-602019-11-13C16284748780-197449f38-b9ed-f6ea-e053-dbdaa90aa703These 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 CIV Initial U.S. Approval: 1992
66336-718-902019-11-13C16284748780-197449f38-b9ed-f6ea-e053-dbdaa90aa703These 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 CIV Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-718-10Zolpidem Tartrate10 in 1 BOTTLETABLET, FILM COATED101
66336-718-15Zolpidem Tartrate15 in 1 BOTTLE, PLASTICTABLET, FILM COATED151
66336-718-30Zolpidem Tartrate30 in 1 BOTTLETABLET, FILM COATED301
66336-718-60Zolpidem Tartrate60 in 1 BOTTLETABLET, FILM COATED601
66336-718-90Zolpidem Tartrate90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66336-718-15EA - Each66336-71848ac7dd6-b999-41ca-ab89-1ce44b8ebc1612013-08-02
66336-718-30EA - Each66336-718605841d9-a543-40c3-9783-f4d54b9e4df412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673ZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673ZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-718ZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 4 package rows20120210_e617f7f2-585c-4eb5-8d35-1fc6d02ef57d.zip
66336-718ZOLPIDEM TARTRATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20130620_f1ebb7d5-9c00-4650-86f3-f5b0954af2ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSNe617f7f2-585c-4eb5-8d35-1fc6d02ef57d1
854873zolpidem tartrate 10 MG Oral TabletPSNf1ebb7d5-9c00-4650-86f3-f5b0954af2ca1
854873zolpidem tartrate 10 MG Oral TabletSCDe617f7f2-585c-4eb5-8d35-1fc6d02ef57d1
854873zolpidem tartrate 10 MG Oral TabletSCDf1ebb7d5-9c00-4650-86f3-f5b0954af2ca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-718-106633607181010 in 1 BOTTLEHistorical
66336-718-156633607181515 in 1 BOTTLE, PLASTICHistorical
66336-718-306633607183030 in 1 BOTTLEHistorical
66336-718-606633607186060 in 1 BOTTLEHistorical
66336-718-906633607189090 in 1 BOTTLEHistorical