phentolamine mesylate

Generic: phentolamine mesylate

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

Drug Facts

Product Profile

Brand Name phentolamine mesylate
Generic Name phentolamine mesylate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

phentolamine mesylate 5 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9564
Product ID 0143-9564_264ee71e-7e33-4693-b993-8ee0cc2f8d48
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040235
Listing Expiration 2026-12-31
Marketing Start 1998-05-15

Pharmacologic Class

Classes
adrenergic alpha-antagonists [moa] alpha-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439564
Hyphenated Format 0143-9564

Supplemental Identifiers

RxCUI
1361023
UNII
Y7543E5K9T

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 phentolamine mesylate (source: ndc)
Generic Name phentolamine mesylate (source: ndc)
Application Number ANDA040235 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX (0143-9564-01) / 1 mL in 1 VIAL
  • 10 VIAL in 1 BOX (0143-9564-10) / 1 mL in 1 VIAL
source: ndc

Packages (2)

0143-9564-01 1 VIAL in 1 BOX (0143-9564-01) / 1 mL in 1 VIAL 0143-9564-10 10 VIAL in 1 BOX (0143-9564-10) / 1 mL in 1 VIAL

Ingredients (1)

phentolamine mesylate (5 mg/mL)

Linked Drug Pages (1)

Phentolamine Mesylate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "264ee71e-7e33-4693-b993-8ee0cc2f8d48", "openfda": {"unii": ["Y7543E5K9T"], "rxcui": ["1361023"], "spl_set_id": ["ed6c506c-5535-4b7c-ae1a-d63f09d796c9"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX (0143-9564-01)  / 1 mL in 1 VIAL", "package_ndc": "0143-9564-01", "marketing_start_date": "20151104"}, {"sample": false, "description": "10 VIAL in 1 BOX (0143-9564-10)  / 1 mL in 1 VIAL", "package_ndc": "0143-9564-10", "marketing_start_date": "20151104"}], "brand_name": "Phentolamine Mesylate", "product_id": "0143-9564_264ee71e-7e33-4693-b993-8ee0cc2f8d48", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "0143-9564", "generic_name": "Phentolamine Mesylate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phentolamine Mesylate", "active_ingredients": [{"name": "PHENTOLAMINE MESYLATE", "strength": "5 mg/mL"}], "application_number": "ANDA040235", "marketing_category": "ANDA", "marketing_start_date": "19980515", "listing_expiration_date": "20261231"}