hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: navinta llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler navinta llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

hydralazine hydrochloride 20 mg/mL

Manufacturer
Navinta LLC

Identifiers & Regulatory

Product NDC 68475-514
Product ID 68475-514_99678e1f-ed3c-48a8-8902-33f407eb0d8c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202938
Listing Expiration 2026-12-31
Marketing Start 2025-11-25

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68475514
Hyphenated Format 68475-514

Supplemental Identifiers

RxCUI
966571
UPC
0368475514010
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 ANDA202938 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 PACKAGE (68475-514-02) / 1 mL in 1 VIAL (68475-514-01)
source: ndc

Packages (1)

68475-514-02 25 VIAL in 1 PACKAGE (68475-514-02) / 1 mL in 1 VIAL (68475-514-01)

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": "99678e1f-ed3c-48a8-8902-33f407eb0d8c", "openfda": {"upc": ["0368475514010"], "unii": ["FD171B778Y"], "rxcui": ["966571"], "spl_set_id": ["ae5d85df-11a3-4952-ade2-596d57cdd987"], "manufacturer_name": ["Navinta LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 PACKAGE (68475-514-02)  / 1 mL in 1 VIAL (68475-514-01)", "package_ndc": "68475-514-02", "marketing_start_date": "20251125"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "68475-514_99678e1f-ed3c-48a8-8902-33f407eb0d8c", "dosage_form": "INJECTION", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "68475-514", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "Navinta LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA202938", "marketing_category": "ANDA", "marketing_start_date": "20251125", "listing_expiration_date": "20261231"}