NDC 70518-1403

HydrALAZINE Hydrochloride

Hydralazine Hydrochloride

HydrALAZINE Hydrochloride 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 ID70518-1403_7f9fc985-febe-ac2a-e053-2a91aa0a492d
NDC70518-1403
Product TypeHuman Prescription Drug
Proprietary NameHydrALAZINE Hydrochloride
Generic NameHydralazine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-09-07
Marketing CategoryANDA / ANDA
Application NumberANDA200770
Labeler NameREMEDYREPACK INC.
Substance NameHYDRALAZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesArteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-1403-0

30 TABLET in 1 BLISTER PACK (70518-1403-0)
Marketing Start Date2018-09-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1403-0 [70518140300]

HydrALAZINE Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA200770
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-07
Marketing End Date2020-05-20

Drug Details

Active Ingredients

IngredientStrength
HYDRALAZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:39b4de9e-12ea-419c-a9b9-0d4c8f6cf181
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 905225

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    67877-293Hydralazine HydrochlorideHydralazine Hydrochloride
    67877-292Hydralazine HydrochlorideHydralazine Hydrochloride
    67877-291Hydralazine HydrochlorideHydralazine Hydrochloride
    67877-290Hydralazine HydrochlorideHydralazine Hydrochloride
    68071-2055Hydralazine HydrochlorideHydralazine Hydrochloride
    68071-2012Hydralazine HydrochlorideHydralazine Hydrochloride
    68071-3279Hydralazine HydrochlorideHydralazine Hydrochloride
    68071-1940Hydralazine HydrochlorideHydralazine Hydrochloride
    68071-4490Hydralazine HydrochlorideHydralazine Hydrochloride
    68084-447Hydralazine HydrochlorideHydralazine Hydrochloride
    68462-341Hydralazine HydrochlorideHydralazine Hydrochloride
    68462-342Hydralazine HydrochlorideHydralazine Hydrochloride
    68462-343Hydralazine HydrochlorideHydralazine Hydrochloride
    68462-344Hydralazine HydrochlorideHydralazine Hydrochloride
    68788-6917Hydralazine HydrochlorideHydralazine Hydrochloride
    68788-7330Hydralazine HydrochlorideHydralazine Hydrochloride
    70518-0479Hydralazine HydrochlorideHydralazine Hydrochloride
    70518-0666Hydralazine HydrochlorideHydralazine Hydrochloride
    70518-0637Hydralazine HydrochlorideHydralazine Hydrochloride
    70518-0832Hydralazine HydrochlorideHydralazine Hydrochloride
    70518-1685Hydralazine HydrochlorideHydralazine Hydrochloride
    70518-1868Hydralazine HydrochlorideHydralazine Hydrochloride
    70518-1403HydrALAZINE HydrochlorideHydrALAZINE Hydrochloride
    71205-091Hydralazine HydrochlorideHydralazine Hydrochloride
    71209-018HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE
    71209-017HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE
    71205-072HydrALAZINE HydrochlorideHydrALAZINE Hydrochloride
    71209-016HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE
    71335-0983Hydralazine HydrochlorideHydralazine Hydrochloride
    71335-0594Hydralazine HydrochlorideHydralazine Hydrochloride
    71335-0202Hydralazine HydrochlorideHydralazine Hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.