NDC 70518-0063

Isosorbide Dinitrate

Isosorbide Dinitrate

Isosorbide Dinitrate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Isosorbide Dinitrate.

Product ID70518-0063_802a58aa-6a65-80dc-e053-2a91aa0a5350
NDC70518-0063
Product TypeHuman Prescription Drug
Proprietary NameIsosorbide Dinitrate
Generic NameIsosorbide Dinitrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-12-14
Marketing CategoryANDA / ANDA
Application NumberANDA086223
Labeler NameREMEDYREPACK INC.
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 70518-0063-0

30 TABLET in 1 BLISTER PACK (70518-0063-0)
Marketing Start Date2016-12-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0063-0 [70518006300]

Isosorbide Dinitrate TABLET
Marketing CategoryANDA
Application NumberANDA086223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-14
Marketing End Date2020-04-01

NDC 70518-0063-1 [70518006301]

Isosorbide Dinitrate TABLET
Marketing CategoryANDA
Application NumberANDA086223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10
Marketing End Date2020-04-01

Drug Details

Active Ingredients

IngredientStrength
ISOSORBIDE DINITRATE10 mg/1

OpenFDA Data

SPL SET ID:b43772a6-954b-476c-b988-f37f4096dca6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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

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