NDC 43353-205

HydrALAZINE Hydrochloride

Hydralazine Hydrochloride

HydrALAZINE Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Hydralazine Hydrochloride.

Product ID43353-205_7ff2351c-0271-49c1-b5d4-cb73b76a508c
NDC43353-205
Product TypeHuman Prescription Drug
Proprietary NameHydrALAZINE Hydrochloride
Generic NameHydralazine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-05-20
Marketing CategoryANDA / ANDA
Application NumberANDA090255
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameHYDRALAZINE HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesArteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43353-205-05

4200 TABLET in 1 BOTTLE (43353-205-05)
Marketing Start Date2016-07-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-205-05 [43353020505]

HydrALAZINE Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090255
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-09

Drug Details

Active Ingredients

IngredientStrength
HYDRALAZINE HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:921c8693-84c2-4313-a2a6-ab3be637d554
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 905222

    • 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
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