FDA.reportPublic FDA data

NDC 68071-1887-01 - 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
68071-1887
Requested NDC
68071-1887-01
Package NDCs from labels
68071-1887-1, 68071-1887-5, 68071-1887-8, 68071-1887-4, 68071-1887-2, 68071-1887-3, 68071-1887-6, 68071-1887-9, 68071-1887-01
Manufacturer
NuCare Pharmaceuticals, Inc | NuCare Pharmaceuticals, Inc.
Effective date
2024-07-16
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.NuCare Pharmaceuticals, Inc | NuCare Pharmaceuticals, Inc.2024-07-16HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-1887-12023-07-03These 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.
68071-1887-22023-07-03These 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.
68071-1887-32023-07-03These 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.
68071-1887-42023-07-03These 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.
68071-1887-52023-07-03These 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.
68071-1887-62023-07-03These 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.
68071-1887-82023-07-03These 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.
68071-1887-92023-07-03These 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.
68071-1887-12023-01-30These 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.
68071-1887-22023-01-30These 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.
68071-1887-32023-01-30These 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.
68071-1887-42023-01-30These 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.
68071-1887-52023-01-30These 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.
68071-1887-62023-01-30These 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.
68071-1887-82023-01-30These 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.
68071-1887-92023-01-30These 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.
68071-1887-12021-02-10These 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.
68071-1887-22021-02-10These 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.
68071-1887-32021-02-10These 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.
68071-1887-42021-02-10These 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.
68071-1887-52021-02-10These 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.
68071-1887-62021-02-10These 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.
68071-1887-82021-02-10These 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.
68071-1887-92021-02-10These 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.
68071-1887-12021-01-29These 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.
68071-1887-22021-01-29These 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.
68071-1887-32021-01-29These 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.
68071-1887-42021-01-29These 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.
68071-1887-52021-01-29These 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.
68071-1887-62021-01-29These 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.
68071-1887-82021-01-29These 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.
68071-1887-92021-01-29These 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
68071-1887-1ZOLPIDEM 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

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 7 of 9 · 176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zolpidem tartrateZOLPIDEM TARTRATEBryant Ranch Prepack82bca7a0-021f-4e35-8b3f-6390eeb863a62024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.95b0ba48-4e71-25f7-e053-2a95a90aea822024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854873
unii: WY6W63843K
CaladrylFERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDEBausch Health US, LLC67d4fd42-9fed-4238-9f5a-c9403abbcf202024-10-17WarningsExact identifier
unii: 1K09F3G675
ZolpidemZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC1e13ad50-f846-813a-e063-6294a90a58782024-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
unii: 1K09F3G675
Zolpidem TartrateZOLPIDEM TARTRATESandoz Inc0553e26c-f2aa-43aa-adf9-6eb951a501d32024-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
Zolpidem tartrateZOLPIDEM TARTRATEBryant Ranch Prepackce301d8b-0a8c-4404-8697-57222ae17a442024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack8cef5718-c562-43c3-8abe-a2fc5235ad2a2024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepackfff2e7fc-2f7e-43c9-bfb3-d929ecc9eb722024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAmerican Health Packagingeb850154-4b4b-4d9a-8476-aea1a93fe8d72024-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEChartwell RX, LLC0dd113e1-f789-48d2-8cb2-d39b712736582024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepack3bbc3c35-2811-4a67-9dcc-5eed38ef8b522024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854873
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEBryant Ranch Prepackf9c108d1-5e2f-41c7-a845-2aed48c309052024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepack604e77ef-2cda-4efc-abfb-9af549d40fd42024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack74c4e793-3444-4d3d-8211-26374349ab1e2024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
unii: WY6W63843K
ZolpidemZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLC1fa86b79-8809-35f4-e063-6394a90a43772024-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.ac8c412a-0f94-7c3a-e053-2995a90afdc72024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854876
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals, Inc4be6ce23-e7b1-510e-e054-00144ff8d46c2024-07-16Warnings, Adverse reactionsExact identifier
application number: ANDA077903
ndc (package): 68071-1887-5
ndc (package): 68071-1887-8
ndc (package): 68071-1887-1
ndc (package): 68071-1887-6
ndc (package): 68071-1887-4
ndc (package): 68071-1887-2
ndc (package): 68071-1887-3
ndc (package): 68071-1887-9
ndc (product): 68071-1887
ndc11 (package): 68071188701
rxcui: 854873
spl id: 1d601044-106a-4c49-e063-6294a90a8080
spl set id: 4be6ce23-e7b1-510e-e054-00144ff8d46c
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDirectRX25f1176d-5195-1a99-e054-00144ff8d46c2024-06-26Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854873
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.98e5208b-5109-58c6-e053-2995a90a994a2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854873
unii: WY6W63843K

Reported adverse events (FAERS/openFDA)#

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