NDC 0091-0920 - Dilatrate-SR

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
0091-0920
Package NDCs from labels
0091-0920-01
Manufacturer
Schwarz Pharma
Effective date
2008-01-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dilatrate-SR - Schwarz PharmaSchwarz Pharma2008-01-23Human prescription drug label
Dilatrate-SR - Schwartz PharmaSchwartz Pharma2006-10-26Human prescription drug label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0091-0920-01Dilatrate-SR100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1001
0091-0920-01Dilatrate-SR100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0091-0920DILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARTZ PHARMA]11 package rows20070119_2A4CD065-A1DD-4B88-9F7A-7BA93502F972.zip
0091-0920DILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARZ PHARMA]11 package rows20080208_49E5A402-A084-4B48-9ADE-1E123F49391E.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Isosorbide DinitrateACTIVE INGREDIENTIA7306519NDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARZ PHARMA]1
Isosorbide DinitrateACTIVE INGREDIENTIA7306519NDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARTZ PHARMA]1
IsosorbideACTIVE MOIETYWXR179L51SDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARTZ PHARMA]1
Isosorbide DinitrateACTIVE MOIETYIA7306519NDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARZ PHARMA]1
D&C Red 33INACTIVE INGREDIENTDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARZ PHARMA]1
D&C Red 33INACTIVE INGREDIENTDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARTZ PHARMA]1
D&C Yellow 10INACTIVE INGREDIENTDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARTZ PHARMA]1
D&C Yellow 10INACTIVE INGREDIENTDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARZ PHARMA]1
EthylcelluloseINACTIVE INGREDIENTDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARTZ PHARMA]1
EthylcelluloseINACTIVE INGREDIENTDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARZ PHARMA]1
GelatinINACTIVE INGREDIENT2G86QN327LDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARZ PHARMA]1
GelatinINACTIVE INGREDIENT2G86QN327LDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARTZ PHARMA]1
LactoseINACTIVE INGREDIENTDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARTZ PHARMA]1
LactoseINACTIVE INGREDIENTJ2B2A4N98GDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARZ PHARMA]1
Pharmaceutical GlazeINACTIVE INGREDIENTDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARZ PHARMA]1
Pharmaceutical GlazeINACTIVE INGREDIENTDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARTZ PHARMA]1
StarchINACTIVE INGREDIENTDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARTZ PHARMA]1
StarchINACTIVE INGREDIENTDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARZ PHARMA]1
SucroseINACTIVE INGREDIENTC151H8M554DILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARTZ PHARMA]1
SucroseINACTIVE INGREDIENTC151H8M554DILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARZ PHARMA]1
TalcINACTIVE INGREDIENT7SEV7J4R1UDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARZ PHARMA]1
TalcINACTIVE INGREDIENT7SEV7J4R1UDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARTZ PHARMA]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARZ PHARMA]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPDILATRATE-SR (ISOSORBIDE DINITRATE) CAPSULE, EXTENDED RELEASE [SCHWARTZ PHARMA]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 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2A4CD065-A1DD-4B88-9F7A-7BA93502F9722A4CD065-A1DD-4B88-9F7A-7BA93502F9722006-10-26Warnings, Adverse reactionsExact identifier
spl id: 2A4CD065-A1DD-4B88-9F7A-7BA93502F972
spl set id: 2A4CD065-A1DD-4B88-9F7A-7BA93502F972

Reported adverse events (FAERS/openFDA)#

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