hydralazine hydrochloride

Generic: hydralazine hydrochloride

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

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 10 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1609
Product ID 67046-1609_41c023cd-3a20-a16a-e063-6294a90a493e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205236
Listing Expiration 2026-12-31
Marketing Start 2025-10-22

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461609
Hyphenated Format 67046-1609

Supplemental Identifiers

RxCUI
905199
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 ANDA205236 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1609-3)
source: ndc

Packages (1)

67046-1609-3 30 TABLET in 1 BLISTER PACK (67046-1609-3)

Ingredients (1)

hydralazine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Hydralazine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41c023cd-3a20-a16a-e063-6294a90a493e", "openfda": {"unii": ["FD171B778Y"], "rxcui": ["905199"], "spl_set_id": ["41c019e3-7b07-5f12-e063-6294a90a5365"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1609-3)", "package_ndc": "67046-1609-3", "marketing_start_date": "20251022"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "67046-1609_41c023cd-3a20-a16a-e063-6294a90a493e", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "67046-1609", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA205236", "marketing_category": "ANDA", "marketing_start_date": "20251022", "listing_expiration_date": "20261231"}