hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler chartwell rx, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 50 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-581
Product ID 62135-581_459c0193-3a85-878d-e063-6294a90afc31
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086242
Listing Expiration 2026-12-31
Marketing Start 2007-04-06

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135581
Hyphenated Format 62135-581

Supplemental Identifiers

RxCUI
905199 905222 905225 905395
UPC
0362135580124 0362135581121 0362135582128 0362135579128
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 ANDA086242 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (62135-581-12)
source: ndc

Packages (1)

62135-581-12 120 TABLET, FILM COATED in 1 BOTTLE (62135-581-12)

Ingredients (1)

hydralazine hydrochloride (50 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": "459c0193-3a85-878d-e063-6294a90afc31", "openfda": {"upc": ["0362135580124", "0362135581121", "0362135582128", "0362135579128"], "unii": ["FD171B778Y"], "rxcui": ["905199", "905222", "905225", "905395"], "spl_set_id": ["0c7f9bd0-6c0a-4521-b77a-3582faa96874"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (62135-581-12)", "package_ndc": "62135-581-12", "marketing_start_date": "20230509"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "62135-581_459c0193-3a85-878d-e063-6294a90afc31", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "62135-581", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA086242", "marketing_category": "ANDA", "marketing_start_date": "20070406", "listing_expiration_date": "20261231"}