FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
53002-5020
11-digit product format
530025020
Labeler code
53002
Product ID
53002-5020_731f90ad-1acc-44df-a71a-012403a98d53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, 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
No
Listing certified through
2021-12-31
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
53002-5020-12025-01-30C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-22025-01-30C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-32025-01-30C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-52025-01-30C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-12023-06-07C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-22023-06-07C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-32023-06-07C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-52023-06-07C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-12023-01-30C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-22023-01-30C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-32023-01-30C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-52023-01-30C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-12020-12-15C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-22020-12-15C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-32020-12-15C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-52020-12-15C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-12020-01-31C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-22020-01-31C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-32020-01-31C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.
53002-5020-52020-01-31C16284748780-19d75b9d0-17b0-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 C IV Initial U.S. Approval: 1992.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-5020-1ZOLPIDEM TARTRATE10 in 1 BOTTLETABLET107
53002-5020-2ZOLPIDEM TARTRATE20 in 1 BOTTLETABLET207
53002-5020-3ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET307
53002-5020-5ZOLPIDEM TARTRATE5 in 1 BOTTLETABLET57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-5020ZOLPIDEM TARTRATE TABLET [RPK PHARMACEUTICALS, INC.]7Legacy NDC, 4 package rows20230609_96d08f88-c841-46d6-958d-7f45656e672c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN96d08f88-c841-46d6-958d-7f45656e672c7
854876zolpidem tartrate 5 MG Oral TabletPSN96d08f88-c841-46d6-958d-7f45656e672c7
854873zolpidem tartrate 10 MG Oral TabletSCD96d08f88-c841-46d6-958d-7f45656e672c7
854876zolpidem tartrate 5 MG Oral TabletSCD96d08f88-c841-46d6-958d-7f45656e672c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-5020-15300250200110 TABLET in 1 BOTTLE (53002-5020-1) 10 tablet2017-10-010000-00-00NoNoCurrent
53002-5020-25300250200220 TABLET in 1 BOTTLE (53002-5020-2) 20 tablet2017-10-010000-00-00NoNoCurrent
53002-5020-35300250200330 TABLET in 1 BOTTLE (53002-5020-3) 30 tablet2017-10-010000-00-00NoNoCurrent
53002-5020-5530025020055 TABLET in 1 BOTTLE (53002-5020-5) 5 tablet2017-10-010000-00-00NoNoCurrent