NDC 70518-1581

Hydralazine

Hydralazine Hydrochloride

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

Product ID70518-1581_790192df-e250-102a-e053-2991aa0a3e4c
NDC70518-1581
Product TypeHuman Prescription Drug
Proprietary NameHydralazine
Generic NameHydralazine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-10-24
Marketing CategoryANDA / ANDA
Application NumberANDA203845
Labeler NameREMEDYREPACK INC.
Substance NameHYDRALAZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesArteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1581-0

30 TABLET in 1 BLISTER PACK (70518-1581-0)
Marketing Start Date2018-10-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1581-0 [70518158100]

Hydralazine TABLET
Marketing CategoryANDA
Application NumberANDA203845
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-24
Marketing End Date2020-05-27

Drug Details

Active Ingredients

IngredientStrength
HYDRALAZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:6cb83415-b806-49dc-99a3-8725290e04fa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 905225
  • Pharmacological Class

    • Arteriolar Vasodilation [PE]
    • Arteriolar Vasodilator [EPC]

    NDC Crossover Matching brand name "Hydralazine" or generic name "Hydralazine Hydrochloride"

    NDCBrand NameGeneric Name
    70518-1581HydralazineHydralazine
    75834-128HydralazineHydralazine
    75834-126HydralazineHydralazine
    75834-127HydralazineHydralazine
    55154-1490HydralazineHydralazine
    55154-1487HydralazineHydralazine
    0404-9875HYDRALAZINE HYDROCHLORIDEhydralazine hydrochloride
    0404-9986HYDRALAZINE HYDROCHLORIDEhydralazine hydrochloride
    0517-0901Hydralazine HydrochlorideHydralazine Hydrochloride
    0615-0516Hydralazine HydrochlorideHydralazine Hydrochloride
    0615-0531Hydralazine HydrochlorideHydralazine Hydrochloride
    0615-0532Hydralazine HydrochlorideHydralazine Hydrochloride
    0615-5649Hydralazine HydrochlorideHydralazine Hydrochloride
    0615-7973Hydralazine HydrochlorideHydralazine Hydrochloride
    0641-6231HydrALAZINE hydrochlorideHydrALAZINE hydrochloride
    0904-6440Hydralazine HydrochlorideHydralazine Hydrochloride
    0904-6441Hydralazine HydrochlorideHydralazine Hydrochloride
    0904-6442Hydralazine HydrochlorideHydralazine Hydrochloride
    0904-6443Hydralazine HydrochlorideHydralazine Hydrochloride
    17478-834Hydralazine HydrochlorideHydralazine Hydrochloride
    17478-934Hydralazine HydrochlorideHydralazine Hydrochloride
    21695-679HYDRALAZINE HYDROCHLORIDEHydralazine Hydrochloride
    21695-680HYDRALAZINE HYDROCHLORIDEHydralazine Hydrochloride
    21695-694HYDRALAZINE HYDROCHLORIDEHydralazine Hydrochloride
    21695-695HYDRALAZINE HYDROCHLORIDEHydralazine Hydrochloride

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