NDC 75834-126

Hydralazine

Hydralazine Hydrochloride

Hydralazine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Nivagen Pharmaceuticals, Inc.. The primary component is Hydralazine Hydrochloride.

Product ID75834-126_379fe677-a8e7-4bfe-abcf-85283768c27b
NDC75834-126
Product TypeHuman Prescription Drug
Proprietary NameHydralazine
Generic NameHydralazine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-02-15
Marketing CategoryANDA / ANDA
Application NumberANDA203845
Labeler NameNivagen Pharmaceuticals, Inc.
Substance NameHYDRALAZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesArteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 75834-126-00

1000 TABLET in 1 BOTTLE (75834-126-00)
Marketing Start Date2017-02-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 75834-126-00 [75834012600]

Hydralazine TABLET
Marketing CategoryANDA
Application NumberANDA203845
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-02-15
Inactivation Date2020-01-31
Reactivation Date2020-05-06

NDC 75834-126-01 [75834012601]

Hydralazine TABLET
Marketing CategoryANDA
Application NumberANDA203845
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-02-15
Inactivation Date2020-01-31
Reactivation Date2020-05-06

Drug Details

Active Ingredients

IngredientStrength
HYDRALAZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:1fd8cf42-66ae-4af5-a5ae-7c9679a0e532
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 905225
  • 905222
  • 905395
  • UPC Code
  • 0375834127019
  • 0375834126012
  • 0375834128016
  • Pharmacological Class

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

    Medicade Reported Pricing

    75834012601 HYDRALAZINE 25 MG TABLET

    Pricing Unit: EA | Drug Type:

    75834012600 HYDRALAZINE 25 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    70518-1581HydralazineHydralazine
    75834-128HydralazineHydralazine
    75834-126HydralazineHydralazine
    75834-127HydralazineHydralazine
    55154-1490HydralazineHydralazine
    55154-1487HydralazineHydralazine
    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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