Home NDC 53489-601-05 NDC 53489-601-05 - 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 53489-601
Requested NDC 53489-601-05
Package NDCs from labels 53489-601-07, 53489-601-06, 53489-601-01, 53489-601-03, 53489-601-05, 53489-601-10
Manufacturer Mutual Pharmaceutical Company, Inc.
Effective date 2007-05-04
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53489-601-01 ZOLPIDEM TARTRATE 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 1 53489-601-03 ZOLPIDEM TARTRATE 250 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 250 1 53489-601-05 ZOLPIDEM TARTRATE 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 1 53489-601-06 ZOLPIDEM TARTRATE 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 1 53489-601-07 ZOLPIDEM TARTRATE 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 1 53489-601-10 ZOLPIDEM TARTRATE 1000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53489-601 ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.] 1 6 package rows 20070524_A0E521C3-7807-464E-922D-CE8F23216828.zip
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Zolpidem Tartrate ACTIVE INGREDIENT WY6W63843K ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.] 1 Zolpidem ACTIVE MOIETY 7K383OQI23 ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.] 1 Carnauba wax INACTIVE INGREDIENT ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.] 1 citric acid INACTIVE INGREDIENT 2968PHW8QP ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.] 1 crospovidone INACTIVE INGREDIENT ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.] 1 hypromellose INACTIVE INGREDIENT ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.] 1 iron oxide red INACTIVE INGREDIENT ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.] 1 lactose monhydrate INACTIVE INGREDIENT ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.] 1 polydextrose INACTIVE INGREDIENT ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.] 1 polyethylene glycol INACTIVE INGREDIENT ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.] 1 povidone INACTIVE INGREDIENT ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.] 1 triacetin INACTIVE INGREDIENT XHX3C3X673 ZOLPIDEM 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 5 of 5 · 81 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.