NDC 61919-312

HYDRALAZINE HYDROCHLORIDE

Hydralazine Hydrochloride

HYDRALAZINE HYDROCHLORIDE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Direct_rx. The primary component is Hydralazine Hydrochloride.

Product ID61919-312_90012980-3cf0-a677-e053-2995a90ad493
NDC61919-312
Product TypeHuman Prescription Drug
Proprietary NameHYDRALAZINE HYDROCHLORIDE
Generic NameHydralazine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-08-13
Marketing CategoryANDA / ANDA
Application NumberANDA086242
Labeler NameDirect_Rx
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 61919-312-90

90 TABLET, FILM COATED in 1 BOTTLE (61919-312-90)
Marketing Start Date2019-08-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-312-90 [61919031290]

HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA086242
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-13

Drug Details

Active Ingredients

IngredientStrength
HYDRALAZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:90012980-3cef-a677-e053-2995a90ad493
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 905225
  • Pharmacological Class

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