FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
68071-1887
11-digit product format
680711887
Labeler code
68071
Product ID
68071-1887_1d601044-106a-4c49-e063-6294a90a8080
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
Substance
ZOLPIDEM TARTRATE
Active strength
10 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZOLPIDEM TARTRATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLPIDEM TARTRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854873

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
68071-1887-12023-07-03C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-22023-07-03C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-32023-07-03C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-42023-07-03C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-52023-07-03C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-62023-07-03C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-82023-07-03C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-92023-07-03C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-12023-01-30C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-22023-01-30C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-32023-01-30C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-42023-01-30C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-52023-01-30C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-62023-01-30C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-82023-01-30C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-92023-01-30C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-12021-02-10C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-22021-02-10C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-32021-02-10C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-42021-02-10C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-52021-02-10C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-62021-02-10C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-82021-02-10C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-92021-02-10C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-12021-01-29C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-22021-01-29C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-32021-01-29C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-42021-01-29C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-52021-01-29C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-62021-01-29C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-82021-01-29C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-92021-01-29C16284748780-1ba0f9c33-1b20-a910-e053-dadaa90a0b85These 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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1887-1ZOLPIDEM TARTRATE10 in 1 BOTTLETABLET106
68071-1887-2ZOLPIDEM TARTRATE20 in 1 BOTTLETABLET206
68071-1887-3ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET306
68071-1887-4ZOLPIDEM TARTRATE14 in 1 BOTTLETABLET146
68071-1887-5ZOLPIDEM TARTRATE15 in 1 BOTTLETABLET156
68071-1887-6ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET606
68071-1887-8ZOLPIDEM TARTRATE28 in 1 BOTTLETABLET286
68071-1887-9ZOLPIDEM TARTRATE90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1887ZOLPIDEM TARTRATE TABLET [NUCARE PHARMACEUTICALS, INC]6Current NDC, Legacy NDC, 8 package rows20240717_4be6ce23-e7b1-510e-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN4be6ce23-e7b1-510e-e054-00144ff8d46c6
854873zolpidem tartrate 10 MG Oral TabletSCD4be6ce23-e7b1-510e-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1887-16807118870110 TABLET in 1 BOTTLE (68071-1887-1) 10 tablet2017-03-290000-00-00NoNoCurrent
68071-1887-26807118870220 TABLET in 1 BOTTLE (68071-1887-2) 20 tablet2017-03-290000-00-00NoNoCurrent
68071-1887-36807118870330 TABLET in 1 BOTTLE (68071-1887-3) 30 tablet2017-03-290000-00-00NoNoCurrent
68071-1887-46807118870414 TABLET in 1 BOTTLE (68071-1887-4) 14 tablet2017-03-290000-00-00NoNoCurrent
68071-1887-56807118870515 TABLET in 1 BOTTLE (68071-1887-5) 15 tablet2017-03-290000-00-00NoNoCurrent
68071-1887-66807118870660 TABLET in 1 BOTTLE (68071-1887-6) 60 tablet2017-03-290000-00-00NoNoCurrent
68071-1887-86807118870828 TABLET in 1 BOTTLE (68071-1887-8) 28 tablet2017-03-290000-00-00NoNoCurrent
68071-1887-96807118870990 TABLET in 1 BOTTLE (68071-1887-9) 90 tablet2017-03-290000-00-00NoNoCurrent