NDC 52584-934

HYDRALAZINE HYDRCHLORIDE

Hydralazine Hydrochloride

HYDRALAZINE HYDRCHLORIDE is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by General Injectables And Vaccines, Inc.. The primary component is Hydralazine Hydrochloride.

Product ID52584-934_2467074d-b884-4806-847c-51db5e3dc75f
NDC52584-934
Product TypeHuman Prescription Drug
Proprietary NameHYDRALAZINE HYDRCHLORIDE
Generic NameHydralazine Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-09-07
Marketing CategoryANDA / ANDA
Application NumberANDA040730
Labeler NameGeneral Injectables and Vaccines, Inc.
Substance NameHYDRALAZINE HYDROCHLORIDE
Active Ingredient Strength20 mg/mL
Pharm ClassesArteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52584-934-01

1 VIAL, SINGLE-DOSE in 1 BAG (52584-934-01) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-09-07
Marketing End Date2022-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-934-01 [52584093401]

HYDRALAZINE HYDROCHLORIDE INJECTION
Marketing CategoryANDA
Application NumberANDA040730
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-07

Drug Details

Active Ingredients

IngredientStrength
HYDRALAZINE HYDROCHLORIDE20 mg/mL

OpenFDA Data

SPL SET ID:061c4a3a-53ac-471b-ac6c-aab10a50b03a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 966571

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    52584-934HYDRALAZINE HYDRCHLORIDEHYDRALAZINE HYDRCHLORIDE
    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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