hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: american regent, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler american regent, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

hydralazine hydrochloride 20 mg/mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-0901
Product ID 0517-0901_5aca9ccd-3ac3-48b6-9372-34ee0eb4b7f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040136
Listing Expiration 2026-12-31
Marketing Start 1997-06-30

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05170901
Hyphenated Format 0517-0901

Supplemental Identifiers

RxCUI
966571
UPC
0305170901257
UNII
FD171B778Y

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hydralazine hydrochloride (source: ndc)
Generic Name hydralazine hydrochloride (source: ndc)
Application Number ANDA040136 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-0901-25) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0517-0901-25 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-0901-25) / 1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

hydralazine hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Hydralazine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "5aca9ccd-3ac3-48b6-9372-34ee0eb4b7f9", "openfda": {"upc": ["0305170901257"], "unii": ["FD171B778Y"], "rxcui": ["966571"], "spl_set_id": ["17210abc-58f6-442e-8ff2-7971333c82f6"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-0901-25)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0517-0901-25", "marketing_start_date": "19970630"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "0517-0901_5aca9ccd-3ac3-48b6-9372-34ee0eb4b7f9", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "0517-0901", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA040136", "marketing_category": "ANDA", "marketing_start_date": "19970630", "listing_expiration_date": "20261231"}