FDA.reportPublic FDA data

NDC 68071-5093-01 - ZOLPIDEM TARTRATE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68071-5093
Requested NDC
68071-5093-01
Package NDCs from labels
68071-5093-3, 68071-5093-1, 68071-5093-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-10-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZOLPIDEM TARTRATE - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-10-22HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-06-19These 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.
2023-01-30These 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.
2021-02-22These 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.
2021-01-29These 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
68071-5093-1ZOLPIDEM TARTRATE10 in 1 BOTTLETABLET105
68071-5093-3ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5093ZOLPIDEM TARTRATE TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 2 package rows20241024_95b0ba48-4e71-25f7-e053-2a95a90aea82.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 9 · 176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutions91511d2f-7066-49a0-90ea-2940d955c85e2025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutionsef72eb73-d058-4ca3-9013-691aae8426fb2025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
unii: WY6W63843K
zolpidem tartrateZOLPIDEM TARTRATEGolden State Medical Supply, Inc.41124767-8ff7-da5d-e063-6394a90a52032025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEBryant Ranch Prepack8425be72-2bbe-4090-b00e-610f1a1646b12025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYKroger Co.6b3e7aac-395f-48cf-9c5e-f7e163724aef2025-11-17WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYHY-VEE, INC415ecfe9-3145-f23e-e063-6394a90adfd82025-11-17WarningsExact identifier
unii: 1K09F3G675
Au Kah Chuen FugicalCALAMINE AND DIPHENHYDRAMINE HYDROCHLORIDZhejiang Dingtai Pharmaceutical Co., Ltd5b4add17-6c3d-4093-826a-2edb41c1d1db2025-11-10WarningsExact identifier
unii: 1K09F3G675
FARGELIN HEMORRHOIDALCALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDEMADISON ONE ACME INC6844ad63-512d-496a-9458-011894185b0d2025-11-10WarningsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE PLUS PRAMOXINE HCLChain Drug Marketing Association Inc1a3f8819-58cf-8923-e063-6394a90a37af2025-11-06WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS NO TOUCH SPRAYPremier Brands of America Inc.36481d67-2346-470b-e063-6294a90aae992025-11-03WarningsExact identifier
unii: 1K09F3G675
ZOLPIDEM TARTRATEZOLPIDEM TARTRATECardinal Health 107, LLC83510333-f07d-4b81-a3ae-2801d114bd312025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854876
unii: WY6W63843K
Calamine PlusCALAMINE PLUS PRAMOXINE HCLAmerisourceBergen Drug Corporationf161e151-4fab-2fbc-e053-2a95a90a54372025-10-30WarningsExact identifier
unii: 1K09F3G675
REMEDY Calazime Skin ProtectantCALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP1295cfcc-5b61-481b-964b-f53ffd0cb58e2025-10-30WarningsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE PLUS PRAMOXINE HCLMeijer Distribution Inc.03c46823-0b1f-4101-e063-6294a90aaf942025-10-30WarningsExact identifier
unii: 1K09F3G675
Aveeno Anti-Itch ConcentratedZINC OXIDE, FERRIC OXIDE RED, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC07f4d4d0-9cee-46c3-bc71-2024abd31c9e2025-10-29WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYPremier Brands of America, Inc.d3452573-f91f-f157-e053-2a95a90a1ad82025-10-27WarningsExact identifier
unii: 1K09F3G675
zolpidem tartrateZOLPIDEM TARTRATEAlmatica Pharma LLC2f1a3600-9bd6-3651-3ab5-1e4e0b0a39162025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEPreferred Pharmaceuticals, Inc.a9ac3d4e-f502-41e3-95c0-0d334584566d2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEPreferred Pharmaceuticals Inc.76ff87e4-3aa2-439d-8436-d9e6affb33c82025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEPreferred Pharmaceuticals, Inc..72e19b8e-d13a-4824-aee4-11778eba552c2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.