NDC 52584-614

Hydralazine Hydrochloride

Hydralazine Hydrochloride

Hydralazine Hydrochloride is a Intramuscular; Intravascular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Hydralazine Hydrochloride.

Product ID52584-614_98fee3fb-4b0e-4ca5-b8d2-6f3a401720e0
NDC52584-614
Product TypeHuman Prescription Drug
Proprietary NameHydralazine Hydrochloride
Generic NameHydralazine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVASCULAR
Marketing Start Date2011-10-19
Marketing CategoryANDA / ANDA
Application NumberANDA040388
Labeler NameGeneral Injectables & Vaccines, Inc
Substance NameHYDRALAZINE HYDROCHLORIDE
Active Ingredient Strength20 mg/mL
Pharm ClassesArteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52584-614-01

1 VIAL in 1 BAG (52584-614-01) > 1 mL in 1 VIAL
Marketing Start Date2011-10-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-614-01 [52584061401]

Hydralazine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA040388
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-19
Marketing End Date2019-03-31

Drug Details

Active Ingredients

IngredientStrength
HYDRALAZINE HYDROCHLORIDE20 mg/mL

OpenFDA Data

SPL SET ID:5df975a6-04bd-4eb9-b1e1-90cd7d06f06b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 966571

    • 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
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