hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler remedyrepack inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

hydralazine hydrochloride 20 mg/mL

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3659
Product ID 70518-3659_3b01d911-7a5c-d4fc-e063-6294a90a57e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040388
Listing Expiration 2026-12-31
Marketing Start 2023-02-27

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183659
Hyphenated Format 70518-3659

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
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (70518-3659-1) / 1 mL in 1 VIAL, SINGLE-DOSE (70518-3659-2)
source: ndc

Packages (1)

70518-3659-1 25 VIAL, SINGLE-DOSE in 1 TRAY (70518-3659-1) / 1 mL in 1 VIAL, SINGLE-DOSE (70518-3659-2)

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": "3b01d911-7a5c-d4fc-e063-6294a90a57e2", "openfda": {"unii": ["FD171B778Y"], "rxcui": ["966571"], "spl_set_id": ["dca82025-a4cd-4856-aa19-bdf091bf8973"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (70518-3659-1)  / 1 mL in 1 VIAL, SINGLE-DOSE (70518-3659-2)", "package_ndc": "70518-3659-1", "marketing_start_date": "20240919"}], "brand_name": "hydrALAZINE Hydrochloride", "product_id": "70518-3659_3b01d911-7a5c-d4fc-e063-6294a90a57e2", "dosage_form": "INJECTION", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "70518-3659", "generic_name": "hydrALAZINE Hydrochloride", "labeler_name": "REMEDYREPACK INC.", "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": "20230227", "listing_expiration_date": "20261231"}