FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
52959-880
11-digit product format
529590880
Labeler code
52959
Product ID
52959-880_67208dcd-25ba-45c9-9e5e-b71747ec6493
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
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
52959-880-102019-10-29C16284748780-1960f7f55-cadf-8e05-e053-dbdaa90a074aThese 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 -CIV Initial U.S. Approval: 1992
52959-880-142019-10-29C16284748780-1960f7f55-cadf-8e05-e053-dbdaa90a074aThese 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 -CIV Initial U.S. Approval: 1992
52959-880-152019-10-29C16284748780-1960f7f55-cadf-8e05-e053-dbdaa90a074aThese 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 -CIV Initial U.S. Approval: 1992
52959-880-202019-10-29C16284748780-1960f7f55-cadf-8e05-e053-dbdaa90a074aThese 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 -CIV Initial U.S. Approval: 1992
52959-880-282019-10-29C16284748780-1960f7f55-cadf-8e05-e053-dbdaa90a074aThese 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 -CIV Initial U.S. Approval: 1992
52959-880-302019-10-29C16284748780-1960f7f55-cadf-8e05-e053-dbdaa90a074aThese 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 -CIV Initial U.S. Approval: 1992
52959-880-422019-10-29C16284748780-1960f7f55-cadf-8e05-e053-dbdaa90a074aThese 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 -CIV Initial U.S. Approval: 1992
52959-880-452019-10-29C16284748780-1960f7f55-cadf-8e05-e053-dbdaa90a074aThese 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 -CIV Initial U.S. Approval: 1992
52959-880-602019-10-29C16284748780-1960f7f55-cadf-8e05-e053-dbdaa90a074aThese 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 -CIV Initial U.S. Approval: 1992
52959-880-902019-10-29C16284748780-1960f7f55-cadf-8e05-e053-dbdaa90a074aThese 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 -CIV Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-880-10ZOLPIDEM TARTRATE10 in 1 BOTTLETABLET101
52959-880-14ZOLPIDEM TARTRATE14 in 1 BOTTLETABLET141
52959-880-15ZOLPIDEM TARTRATE15 in 1 BOTTLETABLET151
52959-880-20ZOLPIDEM TARTRATE20 in 1 BOTTLETABLET201
52959-880-28ZOLPIDEM TARTRATE28 in 1 BOTTLETABLET281
52959-880-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET301
52959-880-42ZOLPIDEM TARTRATE42 in 1 BOTTLETABLET421
52959-880-45ZOLPIDEM TARTRATE45 in 1 BOTTLETABLET451
52959-880-60ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET601
52959-880-90ZOLPIDEM TARTRATE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-880-10EA - Each52959-8802035df18-b627-4ae4-90bd-ca8912db1a3c12012-07-24
52959-880-14EA - Each52959-880eee99fce-4b35-4eb3-a6ce-5d98f1e5e14912012-07-24
52959-880-15EA - Each52959-880dd798a7f-3386-49c6-be21-2cd8ef63355312012-07-24
52959-880-20EA - Each52959-880a93ad19f-45cc-4770-beed-5886026be15312012-07-24
52959-880-28EA - Each52959-88038bd8ca4-e77f-4c2f-8f6e-f5e463299bce12012-07-24
52959-880-30EA - Each52959-8806c4442c0-bc76-4202-8504-add35b0ad46c12012-07-24
52959-880-42EA - Each52959-88053d46b8d-45c9-4dce-bb89-07d704b0d5dd12015-10-02
52959-880-45EA - Each52959-8807df9eff3-2d6b-43f3-9c6b-549b3c50d2f212012-07-24
52959-880-60EA - Each52959-880ac10bbc8-91d9-4ef8-84bb-b9755006c52a12012-07-24
52959-880-90EA - Each52959-88041fcaaef-5ca6-46f5-beee-4d5111e5a0b212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [H.J. HARKINS COMPANY, INC.]1
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-880ZOLPIDEM TARTRATE TABLET [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 10 package rows20110826_9245ff4b-a11f-4afd-8fa0-842fcfee4306.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN9245ff4b-a11f-4afd-8fa0-842fcfee43061
854873zolpidem tartrate 10 MG Oral TabletSCD9245ff4b-a11f-4afd-8fa0-842fcfee43061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-880-105295908801010 in 1 BOTTLEHistorical
52959-880-145295908801414 in 1 BOTTLEHistorical
52959-880-155295908801515 in 1 BOTTLEHistorical
52959-880-205295908802020 in 1 BOTTLEHistorical
52959-880-285295908802828 in 1 BOTTLEHistorical
52959-880-305295908803030 in 1 BOTTLEHistorical
52959-880-425295908804242 in 1 BOTTLEHistorical
52959-880-455295908804545 in 1 BOTTLEHistorical
52959-880-605295908806060 in 1 BOTTLEHistorical
52959-880-905295908809090 in 1 BOTTLEHistorical