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 4 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.78481108-4a1c-fce9-e053-2a91aa0a09ad2024-06-12Warnings, Adverse reactionsExact identifier
rxcui: 854876
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack70d7cfc3-7e54-4cd8-8911-7cf115d5c8202024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack23bce69d-7918-42c2-8020-e22f292ff31f2024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack3aa7e88b-7929-45ac-9e81-03f4abf28e942024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack1e5b61b6-a5bd-4f09-9d34-905ce32f18992024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
Zolpidem TartrateZOLPIDEM TARTRATEAurobindo Pharma Limitedea2067bd-1622-4d98-8012-2c09405aa88d2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
Zolpidem TartrateZOLPIDEM TARTRATENorthStar Rx LLC51c9a29c-a285-40d0-bf3a-7e8c944ee39c2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepackdf130798-1458-455b-a4e1-c33c4ecee43b2023-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack33094305-4bbd-4b52-9079-8853d5f836822023-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
ZolpidemZOLPIDEM TARTRATEACI Healthcare USA, Inc021153ce-fe27-4ed1-8d88-b4157b0ed7342023-11-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEA-S Medication Solutionse68a1b3b-b3d1-495e-be46-466113e7dbd62023-09-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutions67cc924a-26e0-431f-9160-32c9d92a46cd2023-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
ZolpidemZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC8581cfad-525b-4b16-b116-a5138d9fda522022-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
ZolpidemZOLPIDEM TARTRATEProficient Rx LPf76eb9d8-ca7d-4479-bd16-52a57f623b022022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEProficient Rx LPeaca34da-2b12-4dd4-91b5-a8446c7bd41e2022-07-01Warnings, Adverse reactionsExact identifier
rxcui: 854873
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEProficient Rx LPe1f43bde-efba-42be-adef-94e1ef6664fd2022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 854876
Zolpidem TartrateZOLPIDEM TARTRATEProficient Rx LPe534b3ac-1110-465f-8692-6ea585996fb62019-11-01Warnings, Adverse reactionsExact identifier
rxcui: 854873
Zolpidem TartrateZOLPIDEM TARTRATEProficient Rx LPe8572fd4-70c7-4c94-a0d7-9b4be6fa8f772019-11-01Warnings, Adverse reactionsExact identifier
rxcui: 854876
Zolpidem TartrateZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLCacfcfe91-83a0-44ab-95c0-dd98b73ac69a2019-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
Zolpidem TartrateZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC7be7f243-e6f8-406f-aed7-be7cedd5630a2018-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876

Reported adverse events (FAERS/openFDA)#

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