FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
68071-4598
11-digit product format
680714598
Labeler code
68071
Product ID
68071-4598_1ab5fa64-9a29-38ca-e063-6394a90a51b2
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
5 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 TARTRATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854876

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
68071-4598-32024-06-12C16284748780-1ba0f9c33-4f55-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.
68071-4598-42024-06-12C16284748780-1ba0f9c33-4f55-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.
68071-4598-52024-06-12C16284748780-1ba0f9c33-4f55-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.
68071-4598-32023-01-30C16284748780-1ba0f9c33-4f55-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.
68071-4598-42023-01-30C16284748780-1ba0f9c33-4f55-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.
68071-4598-52023-01-30C16284748780-1ba0f9c33-4f55-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.
68071-4598-32021-02-22C16284748780-1ba0f9c33-4f55-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.
68071-4598-42021-02-22C16284748780-1ba0f9c33-4f55-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.
68071-4598-52021-02-22C16284748780-1ba0f9c33-4f55-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.
68071-4598-32021-01-29C16284748780-1ba0f9c33-4f55-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.
68071-4598-42021-01-29C16284748780-1ba0f9c33-4f55-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.
68071-4598-52021-01-29C16284748780-1ba0f9c33-4f55-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
68071-4598-3ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET305
68071-4598-4ZOLPIDEM TARTRATE14 in 1 BOTTLETABLET145
68071-4598-5ZOLPIDEM TARTRATE45 in 1 BOTTLETABLET455

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4598ZOLPIDEM TARTRATE TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 3 package rows20240614_78481108-4a1c-fce9-e053-2a91aa0a09ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSN78481108-4a1c-fce9-e053-2a91aa0a09ad5
854876zolpidem tartrate 5 MG Oral TabletSCD78481108-4a1c-fce9-e053-2a91aa0a09ad5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4598-36807145980330 TABLET in 1 BOTTLE (68071-4598-3) 30 tablet2018-10-150000-00-00NoNoCurrent
68071-4598-46807145980414 TABLET in 1 BOTTLE (68071-4598-4) 14 tablet2018-10-150000-00-00NoNoCurrent
68071-4598-56807145980545 TABLET in 1 BOTTLE (68071-4598-5) 45 tablet2018-10-150000-00-00NoNoCurrent