NDC 0143-1771

Isosorbide Dinitrate

Isosorbide Dinitrate

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

Product ID0143-1771_182efc8b-b356-431e-b49e-8abb83ab3162
NDC0143-1771
Product TypeHuman Prescription Drug
Proprietary NameIsosorbide Dinitrate
Generic NameIsosorbide Dinitrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1978-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA086066
Labeler NameWest-Ward Pharmaceuticals Corp
Substance NameISOSORBIDE DINITRATE
Active Ingredient Strength10 mg/1
Pharm ClassesNitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0143-1771-01

100 TABLET in 1 BOTTLE, PLASTIC (0143-1771-01)
Marketing Start Date1978-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-1771-05 [00143177105]

Isosorbide Dinitrate TABLET
Marketing CategoryANDA
Application NumberANDA086066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1978-12-01
Marketing End Date2014-12-29

NDC 0143-1771-01 [00143177101]

Isosorbide Dinitrate TABLET
Marketing CategoryANDA
Application NumberANDA086066
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1978-12-01

NDC 0143-1771-30 [00143177130]

Isosorbide Dinitrate TABLET
Marketing CategoryANDA
Application NumberANDA086066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1978-12-01
Marketing End Date2014-12-29

NDC 0143-1771-09 [00143177109]

Isosorbide Dinitrate TABLET
Marketing CategoryANDA
Application NumberANDA086066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1978-12-01
Marketing End Date2014-12-29

NDC 0143-1771-25 [00143177125]

Isosorbide Dinitrate TABLET
Marketing CategoryANDA
Application NumberANDA086066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1978-12-01
Marketing End Date2014-12-29

NDC 0143-1771-10 [00143177110]

Isosorbide Dinitrate TABLET
Marketing CategoryANDA
Application NumberANDA086066
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1978-12-01
Marketing End Date2014-12-29

Drug Details

Active Ingredients

IngredientStrength
ISOSORBIDE DINITRATE10 mg/1

OpenFDA Data

SPL SET ID:f0b9b320-0bf8-4342-b654-135ccb6755c2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314055
  • 206842
  • 381056
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.