hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

hydralazine hydrochloride 20 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1376
Product ID 51662-1376_103515bd-ec41-5646-e063-6394a90ae3b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040388
Listing Expiration 2026-12-31
Marketing Start 2019-12-09

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621376
Hyphenated Format 51662-1376

Supplemental Identifiers

RxCUI
966571
UNII
FD171B778Y

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 ANDA040388 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 mL in 1 VIAL, SINGLE-DOSE (51662-1376-1)
  • 25 POUCH in 1 BOX (51662-1376-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1376-2) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

51662-1376-1 1 mL in 1 VIAL, SINGLE-DOSE (51662-1376-1) 51662-1376-3 25 POUCH in 1 BOX (51662-1376-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1376-2) / 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": "103515bd-ec41-5646-e063-6394a90ae3b4", "openfda": {"unii": ["FD171B778Y"], "rxcui": ["966571"], "spl_set_id": ["9949407f-e410-7f47-e053-2995a90a7369"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 VIAL, SINGLE-DOSE (51662-1376-1)", "package_ndc": "51662-1376-1", "marketing_start_date": "20191209"}, {"sample": false, "description": "25 POUCH in 1 BOX (51662-1376-3)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1376-2)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "51662-1376-3", "marketing_start_date": "20210511"}], "brand_name": "HYDRALAZINE HYDROCHLORIDE", "product_id": "51662-1376_103515bd-ec41-5646-e063-6394a90ae3b4", "dosage_form": "INJECTION", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "51662-1376", "generic_name": "HYDRALAZINE HYDROCHLORIDE", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDRALAZINE HYDROCHLORIDE", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA040388", "marketing_category": "ANDA", "marketing_start_date": "20191209", "listing_expiration_date": "20261231"}