FDA.reportPublic FDA data

NDC 53489-600 - 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
53489-600
Package NDCs from labels
53489-600-07, 53489-600-06, 53489-600-01, 53489-600-03, 53489-600-05, 53489-600-10
Manufacturer
Mutual Pharmaceutical Company, Inc.
Effective date
2007-05-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZOLPIDEM TARTRATE - Mutual Pharmaceutical Company, Inc.Mutual Pharmaceutical Company, Inc.2007-05-04HUMAN PRESCRIPTION DRUG LABEL WITH HIGHLIGHTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53489-600-01ZOLPIDEM TARTRATE100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
53489-600-03ZOLPIDEM TARTRATE250 in 1 BOTTLE, PLASTICTABLET, FILM COATED2501
53489-600-05ZOLPIDEM TARTRATE500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5001
53489-600-06ZOLPIDEM TARTRATE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
53489-600-07ZOLPIDEM TARTRATE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
53489-600-10ZOLPIDEM TARTRATE1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-600ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]16 package rows20070524_A0E521C3-7807-464E-922D-CE8F23216828.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Zolpidem TartrateACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
ZolpidemACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
Carnauba waxINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
citric acidINACTIVE INGREDIENT2968PHW8QPZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
crospovidoneINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
hypromelloseINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
iron oxide redINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
lactose monhydrateINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
polydextroseINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
polyethylene glycolINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
povidoneINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
triacetinINACTIVE INGREDIENTXHX3C3X673ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]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.