FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
43353-620
11-digit product format
433530620
Labeler code
43353
Product ID
43353-620_e3b4f606-6863-49a5-be7c-48d86b85bdaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078616
Marketing category
ANDA
Marketing start
2008-11-21
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
2019-12-31
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
43353-620-072020-01-31C16284748780-19d75b9d0-7bca-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, for oral use CIV Initial U.S. Approval: 1992
43353-620-102020-01-31C16284748780-19d75b9d0-7bca-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, for oral use CIV Initial U.S. Approval: 1992
43353-620-142020-01-31C16284748780-19d75b9d0-7bca-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, for oral use CIV Initial U.S. Approval: 1992
43353-620-152020-01-31C16284748780-19d75b9d0-7bca-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, for oral use CIV Initial U.S. Approval: 1992
43353-620-202020-01-31C16284748780-19d75b9d0-7bca-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, for oral use CIV Initial U.S. Approval: 1992
43353-620-282020-01-31C16284748780-19d75b9d0-7bca-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, for oral use CIV Initial U.S. Approval: 1992
43353-620-302020-01-31C16284748780-19d75b9d0-7bca-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, for oral use CIV Initial U.S. Approval: 1992
43353-620-452020-01-31C16284748780-19d75b9d0-7bca-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, for oral use CIV Initial U.S. Approval: 1992
43353-620-532020-01-31C16284748780-19d75b9d0-7bca-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, for oral use CIV Initial U.S. Approval: 1992
43353-620-592020-01-31C16284748780-19d75b9d0-7bca-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, for oral use CIV Initial U.S. Approval: 1992
43353-620-602020-01-31C16284748780-19d75b9d0-7bca-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, for oral use CIV Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-620-07Zolpidem Tartrate7 in 1 BOTTLE, PLASTICTABLET, FILM COATED72
43353-620-10Zolpidem Tartrate10 in 1 BOTTLE, PLASTICTABLET, FILM COATED102
43353-620-14Zolpidem Tartrate14 in 1 BOTTLE, PLASTICTABLET, FILM COATED142
43353-620-15Zolpidem Tartrate15 in 1 BOTTLE, PLASTICTABLET, FILM COATED152
43353-620-20Zolpidem Tartrate20 in 1 BOTTLE, PLASTICTABLET, FILM COATED202
43353-620-28Zolpidem Tartrate28 in 1 BOTTLE, PLASTICTABLET, FILM COATED282
43353-620-30Zolpidem Tartrate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
43353-620-45Zolpidem Tartrate45 in 1 BOTTLE, PLASTICTABLET, FILM COATED452
43353-620-53Zolpidem Tartrate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
43353-620-59Zolpidem Tartrate22 in 1 BOTTLE, PLASTICTABLET, FILM COATED222
43353-620-60Zolpidem Tartrate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-620-07EA - Each43353-620b13b54c8-9b94-4faa-9c49-fdafbabb7c4c12013-02-13
43353-620-10EA - Each43353-6200b62acb3-2439-4b76-94e3-3d7016edd51812013-02-13
43353-620-14EA - Each43353-620d7b59410-7354-43b5-b857-a5e76e927da512013-02-13
43353-620-15EA - Each43353-620bee02fdb-c522-403b-b6a4-1c16a5ea126712013-02-13
43353-620-20EA - Each43353-620293dd8a0-2273-4049-a8c5-d071296a685a12013-02-13
43353-620-28EA - Each43353-62015fb52cc-c22d-43f5-8947-71e7b050a44812013-02-13
43353-620-30EA - Each43353-620e34353ad-65d0-49a7-82e2-6fa9e764db2a12013-02-13
43353-620-45EA - Each43353-620c25f2bf2-9f40-41c9-9806-550aac14c3fe12013-02-13
43353-620-53EA - Each43353-620625b35e7-55d5-49d8-8d1a-f5615e2f3b4c12013-02-13
43353-620-59EA - Each43353-620bdc6f738-46f3-4047-a019-234a2bc3210112013-02-13
43353-620-60EA - Each43353-6204524ff33-fff7-41bf-83b1-cc23bf44f5b112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-620ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 11 package rows20140416_cace3d8a-cbb5-4072-9bce-28219b4909ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSNcace3d8a-cbb5-4072-9bce-28219b4909ae2
854876zolpidem tartrate 5 MG Oral TabletPSNcace3d8a-cbb5-4072-9bce-28219b4909ae2
854873zolpidem tartrate 10 MG Oral TabletSCDcace3d8a-cbb5-4072-9bce-28219b4909ae2
854876zolpidem tartrate 5 MG Oral TabletSCDcace3d8a-cbb5-4072-9bce-28219b4909ae2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-620-07433530620077 in 1 BOTTLE, PLASTICHistorical
43353-620-104335306201010 in 1 BOTTLE, PLASTICHistorical
43353-620-144335306201414 in 1 BOTTLE, PLASTICHistorical
43353-620-154335306201515 in 1 BOTTLE, PLASTICHistorical
43353-620-204335306202020 in 1 BOTTLE, PLASTICHistorical
43353-620-284335306202828 in 1 BOTTLE, PLASTICHistorical
43353-620-304335306203030 in 1 BOTTLE, PLASTICHistorical
43353-620-454335306204545 in 1 BOTTLE, PLASTICHistorical
43353-620-534335306205360 in 1 BOTTLE, PLASTICHistorical
43353-620-594335306205922 in 1 BOTTLE, PLASTICHistorical
43353-620-604335306206090 in 1 BOTTLE, PLASTICHistorical