hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

hydralazine hydrochloride 20 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6231
Product ID 0641-6231_e0fe7653-bdb1-42fc-8277-fc07794f85d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213667
Listing Expiration 2026-12-31
Marketing Start 2020-12-18

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416231
Hyphenated Format 0641-6231

Supplemental Identifiers

RxCUI
966571
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 ANDA213667 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6231-25) / 20 mL in 1 VIAL, SINGLE-DOSE (0641-6231-01)
source: ndc

Packages (1)

0641-6231-25 25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6231-25) / 20 mL in 1 VIAL, SINGLE-DOSE (0641-6231-01)

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": "e0fe7653-bdb1-42fc-8277-fc07794f85d5", "openfda": {"unii": ["FD171B778Y"], "rxcui": ["966571"], "spl_set_id": ["3f5f1204-d289-40e9-be84-a29352f64bfb"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6231-25)  / 20 mL in 1 VIAL, SINGLE-DOSE (0641-6231-01)", "package_ndc": "0641-6231-25", "marketing_start_date": "20201218"}], "brand_name": "HydrALAZINE hydrochloride", "product_id": "0641-6231_e0fe7653-bdb1-42fc-8277-fc07794f85d5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "0641-6231", "generic_name": "HydrALAZINE hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HydrALAZINE hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA213667", "marketing_category": "ANDA", "marketing_start_date": "20201218", "listing_expiration_date": "20261231"}