NDC 0143-1765

Isosorbide Dinitrate

Isosorbide Dinitrate

Isosorbide Dinitrate is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceutical Corp. The primary component is Isosorbide Dinitrate.

Product ID0143-1765_b7c4af42-2c43-4c96-8c33-3711f10cb904
NDC0143-1765
Product TypeHuman Prescription Drug
Proprietary NameIsosorbide Dinitrate
Generic NameIsosorbide Dinitrate
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date1978-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA086054
Labeler NameWest-ward Pharmaceutical Corp
Substance NameISOSORBIDE DINITRATE
Active Ingredient Strength3 mg/1
Pharm ClassesNitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 0143-1765-10

1000 TABLET in 1 BOTTLE (0143-1765-10)
Marketing Start Date1978-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-1765-25 [00143176525]

Isosorbide Dinitrate TABLET
Marketing CategoryANDA
Application NumberANDA086054
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1978-12-01
Inactivation Date2020-01-31

NDC 0143-1765-10 [00143176510]

Isosorbide Dinitrate TABLET
Marketing CategoryANDA
Application NumberANDA086054
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1978-12-01
Inactivation Date2020-01-31

NDC 0143-1765-01 [00143176501]

Isosorbide Dinitrate TABLET
Marketing CategoryANDA
Application NumberANDA086054
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1978-12-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ISOSORBIDE DINITRATE2.5 mg/1

OpenFDA Data

SPL SET ID:44ede034-1fa1-4993-9aa5-49e04fada541
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197838
  • 197841
  • UPC Code
  • 0301431767013
  • 0301431765019
  • Pharmacological Class

    • Nitrate Vasodilator [EPC]
    • Nitrates [CS]
    • Vasodilation [PE]

    NDC Crossover Matching brand name "Isosorbide Dinitrate" or generic name "Isosorbide Dinitrate"

    NDCBrand NameGeneric Name
    0143-1765Isosorbide DinitrateIsosorbide Dinitrate
    0143-1767Isosorbide DinitrateIsosorbide Dinitrate
    0143-1769Isosorbide DinitrateIsosorbide Dinitrate
    0143-1771Isosorbide DinitrateIsosorbide Dinitrate
    0143-1772Isosorbide DinitrateIsosorbide Dinitrate
    0615-1560Isosorbide DinitrateIsosorbide Dinitrate
    0615-1575Isosorbide DinitrateIsosorbide Dinitrate
    0615-7584Isosorbide Dinitrateisosorbide dinitrate
    0615-7902Isosorbide DinitrateIsosorbide Dinitrate
    0615-7903Isosorbide DinitrateIsosorbide Dinitrate
    0615-8157Isosorbide Dinitrateisosorbide dinitrate
    0615-8193Isosorbide Dinitrateisosorbide dinitrate
    0615-8294Isosorbide Dinitrateisosorbide dinitrate
    0781-1556Isosorbide DinitrateIsosorbide Dinitrate
    0781-1635Isosorbide DinitrateIsosorbide Dinitrate
    0781-1695Isosorbide DinitrateIsosorbide Dinitrate
    0904-6619Isosorbide DinitrateIsosorbide Dinitrate
    68001-225Isosorbide DinitrateIsosorbide Dinitrate
    68001-222Isosorbide DinitrateIsosorbide Dinitrate
    68001-223Isosorbide DinitrateIsosorbide Dinitrate
    68084-082Isosorbide DinitrateIsosorbide Dinitrate
    68084-083Isosorbide DinitrateIsosorbide Dinitrate
    68151-2476Isosorbide DinitrateIsosorbide Dinitrate
    68151-2472Isosorbide DinitrateIsosorbide Dinitrate
    68084-894Isosorbide DinitrateIsosorbide Dinitrate
    68151-1980Isosorbide DinitrateIsosorbide Dinitrate
    68151-2510ISOSORBIDE DINITRATEISOSORBIDE DINITRATE
    68151-2475Isosorbide DinitrateIsosorbide Dinitrate
    70518-0063Isosorbide DinitrateIsosorbide Dinitrate
    70518-1435Isosorbide DinitrateIsosorbide Dinitrate
    0904-6620Isosorbide DinitrateIsosorbide Dinitrate
    42291-350Isosorbide DinitrateIsosorbide Dinitrate
    43353-141Isosorbide DinitrateIsosorbide Dinitrate
    43353-139Isosorbide DinitrateIsosorbide Dinitrate
    49884-022Isosorbide DinitrateIsosorbide Dinitrate
    49884-009Isosorbide DinitrateIsosorbide Dinitrate
    49884-020Isosorbide DinitrateIsosorbide Dinitrate
    49884-021Isosorbide DinitrateIsosorbide Dinitrate
    50268-449Isosorbide DinitrateIsosorbide Dinitrate
    50268-447Isosorbide DinitrateIsosorbide Dinitrate
    50268-448Isosorbide DinitrateIsosorbide Dinitrate
    51407-148Isosorbide DinitrateIsosorbide Dinitrate
    51407-149Isosorbide DinitrateIsosorbide Dinitrate
    51407-147Isosorbide DinitrateIsosorbide Dinitrate
    53808-0626Isosorbide DinitrateIsosorbide Dinitrate
    55154-5406Isosorbide DinitrateIsosorbide Dinitrate
    55154-5407Isosorbide DinitrateIsosorbide Dinitrate
    57664-600ISOSORBIDE DINITRATEISOSORBIDE DINITRATE
    60429-442Isosorbide DinitrateIsosorbide Dinitrate
    60429-441Isosorbide DinitrateIsosorbide Dinitrate

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