FDA.reportPublic FDA data

NDC 0591-3367 - 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
0591-3367
Package NDCs from labels
0591-3367-01, 0591-3367-05
Manufacturer
Watson Laboratories
Effective date
2007-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zolpidem Tartrate - Watson LaboratoriesWatson Laboratories2007-05-15HUMAN PRESCRIPTION DRUG LABEL WITH HIGHLIGHTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-3367-01Zolpidem Tartrate100 in 1 BOTTLETABLET1001
0591-3367-05Zolpidem Tartrate500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3367ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [WATSON LABORATORIES]12 package rows20070524_A24DF8D2-E3EA-4224-AE4D-FFEB3E4BBDF1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Zolpidem TartrateACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [WATSON LABORATORIES]1
ZolpidemACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [WATSON LABORATORIES]1
colloidial silicon dioxideINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [WATSON LABORATORIES]1
crosprovidoneINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [WATSON LABORATORIES]1
hypromelloseINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [WATSON LABORATORIES]1
iron oxide redINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [WATSON LABORATORIES]1
lactose monohydrteINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [WATSON LABORATORIES]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [WATSON LABORATORIES]1
microcrystalline celluloseINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [WATSON LABORATORIES]1
polyethylene glycolINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [WATSON LABORATORIES]1
polysorbate 80INACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [WATSON LABORATORIES]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [WATSON LABORATORIES]1

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 3 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCfc76ab4c-3607-39c3-e053-6394a90a68772024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCf939549f-14a6-d37c-e053-6294a90a034a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
ZOLPIDEM TARTRATEZOLPIDEM TARTRATELake Erie Medical DBA Quality Care Products LLCdb735db9-1c82-4d32-bf91-97b05a75e8762024-12-17Warnings, Adverse reactionsExact identifier
rxcui: 854873
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutions3ba3c29f-3835-4f4f-a39f-56fb42686f5b2024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.95b0ba48-4e71-25f7-e053-2a95a90aea822024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
ZolpidemZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC1e13ad50-f846-813a-e063-6294a90a58782024-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
Zolpidem TartrateZOLPIDEM TARTRATESandoz Inc0553e26c-f2aa-43aa-adf9-6eb951a501d32024-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack8cef5718-c562-43c3-8abe-a2fc5235ad2a2024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepackfff2e7fc-2f7e-43c9-bfb3-d929ecc9eb722024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
Zolpidem TartrateZOLPIDEM TARTRATEAmerican Health Packagingeb850154-4b4b-4d9a-8476-aea1a93fe8d72024-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
Zolpidem TartrateZOLPIDEM TARTRATEChartwell RX, LLC0dd113e1-f789-48d2-8cb2-d39b712736582024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepack3bbc3c35-2811-4a67-9dcc-5eed38ef8b522024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
Zolpidem TartrateZOLPIDEM TARTRATEBryant Ranch Prepackf9c108d1-5e2f-41c7-a845-2aed48c309052024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack74c4e793-3444-4d3d-8211-26374349ab1e2024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
ZolpidemZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLC1fa86b79-8809-35f4-e063-6394a90a43772024-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.ac8c412a-0f94-7c3a-e053-2995a90afdc72024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals, Inc4be6ce23-e7b1-510e-e054-00144ff8d46c2024-07-16Warnings, Adverse reactionsExact identifier
rxcui: 854873
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDirectRX25f1176d-5195-1a99-e054-00144ff8d46c2024-06-26Warnings, Adverse reactionsExact identifier
rxcui: 854873
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.98e5208b-5109-58c6-e053-2995a90a994a2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.92c6cc45-c28b-729b-e053-2a95a90a7ccb2024-06-19Warnings, Adverse reactionsExact identifier
rxcui: 854873

Reported adverse events (FAERS/openFDA)#

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