FDA.reportPublic FDA data

NDC 68462-280 - 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
68462-280
Package NDCs from labels
68462-280-01, 68462-280-05
Manufacturer
InvaGen Pharmaceuticals Inc.,
Effective date
2008-02-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zolpidem tartrate - InvaGen Pharmaceuticals Inc.,InvaGen Pharmaceuticals Inc.,2008-02-11HUMAN PRESCRIPTION DRUG LABEL.PLR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-280-01Zolpidem tartrate100 in 1 BOTTLETABLET1002
68462-280-05Zolpidem tartrate500 in 1 BOTTLETABLET5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-280ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [INVAGEN PHARMACEUTICALS INC.,]22 package rows20080222_1f1490cd-b11b-40cb-96be-865730c989e1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-280-01EA - Each68462-28049c03973-10e7-4a4a-a847-080527a5721a12013-02-13
68462-280-05EA - Each68462-280512fa924-c36f-4ec3-bdf3-eef63c12471412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Zolpidem tartrateACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [INVAGEN PHARMACEUTICALS INC.,]2
ZolpidemACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [INVAGEN PHARMACEUTICALS INC.,]2
Hydroxy Propyl Methyl CelluloseINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [INVAGEN PHARMACEUTICALS INC.,]2
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [INVAGEN PHARMACEUTICALS INC.,]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [INVAGEN PHARMACEUTICALS INC.,]2
Microcrystalline celluloseINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [INVAGEN PHARMACEUTICALS INC.,]2
Opadry Pink 03B14436INACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [INVAGEN PHARMACEUTICALS INC.,]2
Opadry White YS-1-7003INACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [INVAGEN PHARMACEUTICALS INC.,]2
Sodium starch glycolateINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR ORAL USE - CIV [INVAGEN PHARMACEUTICALS INC.,]2

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 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zolpidem TartrateZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC7abb6898-223c-487b-856c-068ac04f7a5c2018-09-25Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
1382A811-331E-2842-5E8D-1395439E1CA31f1490cd-b11b-40cb-96be-865730c989e12008-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 1382A811-331E-2842-5E8D-1395439E1CA3
spl set id: 1f1490cd-b11b-40cb-96be-865730c989e1

Reported adverse events (FAERS/openFDA)#

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