NDC 0517-0901

Hydralazine Hydrochloride

Hydralazine Hydrochloride

Hydralazine Hydrochloride is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by American Regent, Inc.. The primary component is Hydralazine Hydrochloride.

Product ID0517-0901_5aca9ccd-3ac3-48b6-9372-34ee0eb4b7f9
NDC0517-0901
Product TypeHuman Prescription Drug
Proprietary NameHydralazine Hydrochloride
Generic NameHydralazine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date1997-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA040136
Labeler NameAmerican Regent, 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 0517-0901-25

25 VIAL, SINGLE-DOSE in 1 TRAY (0517-0901-25) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date1997-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0517-0901-25 [00517090125]

Hydralazine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040136
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-06-30

Drug Details

Active Ingredients

IngredientStrength
HYDRALAZINE HYDROCHLORIDE20 mg/mL

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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