NDC 63323-614

Hydralazine Hydrochloride

Hydralazine Hydrochloride

Hydralazine Hydrochloride is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Hydralazine Hydrochloride.

Product ID63323-614_1923ba75-b4cc-4205-b512-b45326c59df0
NDC63323-614
Product TypeHuman Prescription Drug
Proprietary NameHydralazine Hydrochloride
Generic NameHydralazine Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2011-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA040388
Labeler NameFresenius Kabi USA, LLC
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 63323-614-55

25 VIAL, SINGLE-DOSE in 1 TRAY (63323-614-55) > 1 mL in 1 VIAL, SINGLE-DOSE (63323-614-21)
Marketing Start Date2011-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-614-21 [63323061421]

Hydralazine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA040388
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-14

NDC 63323-614-16 [63323061416]

Hydralazine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA040388
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2001-09-05

NDC 63323-614-55 [63323061455]

Hydralazine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA040388
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-01-31

NDC 63323-614-01 [63323061401]

Hydralazine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA040388
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2001-09-05

NDC 63323-614-00 [63323061400]

Hydralazine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA040388
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-06-13

Drug Details

Active Ingredients

IngredientStrength
HYDRALAZINE HYDROCHLORIDE20 mg/mL

OpenFDA Data

SPL SET ID:8223c44a-73a9-4da5-a468-d1d8bdb0bbd6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 966571
  • UPC Code
  • 0363323614164
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.