hydralazine hydrochloride

Generic: hydralazine hydrochloride

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

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 10 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 50111-398
Product ID 50111-398_faf6c313-03e6-4bf8-ac9f-65642ae10097
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089097
Listing Expiration 2026-12-31
Marketing Start 1990-09-30

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50111398
Hyphenated Format 50111-398

Supplemental Identifiers

RxCUI
905199 905222 905225 905395
UPC
0350111327016 0350111398016 0350111328013
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 ANDA089097 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (50111-398-01)
  • 1000 TABLET in 1 BOTTLE (50111-398-03)
source: ndc

Packages (2)

50111-398-01 100 TABLET in 1 BOTTLE (50111-398-01) 50111-398-03 1000 TABLET in 1 BOTTLE (50111-398-03)

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": "faf6c313-03e6-4bf8-ac9f-65642ae10097", "openfda": {"upc": ["0350111327016", "0350111398016", "0350111328013"], "unii": ["FD171B778Y"], "rxcui": ["905199", "905222", "905225", "905395"], "spl_set_id": ["ddbbdb09-3202-42d7-bbb0-08331dde2f54"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (50111-398-01)", "package_ndc": "50111-398-01", "marketing_start_date": "19900930"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (50111-398-03)", "package_ndc": "50111-398-03", "marketing_start_date": "19900930"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "50111-398_faf6c313-03e6-4bf8-ac9f-65642ae10097", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "50111-398", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA089097", "marketing_category": "ANDA", "marketing_start_date": "19900930", "listing_expiration_date": "20261231"}