phentolamine mesylate

Generic: phentolamine mesylate

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

Drug Facts

Product Profile

Brand Name phentolamine mesylate
Generic Name phentolamine mesylate
Labeler precision dose inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

phentolamine mesylate 5 mg/1

Manufacturer
Precision Dose Inc.

Identifiers & Regulatory

Product NDC 68094-101
Product ID 68094-101_4ecf4179-a773-4f75-a48b-a0b2c51facc2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207686
Listing Expiration 2026-12-31
Marketing Start 2017-07-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68094101
Hyphenated Format 68094-101

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 ANDA207686 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68094-101-20) / 1 INJECTION in 1 VIAL
source: ndc

Packages (1)

68094-101-20 1 VIAL in 1 CARTON (68094-101-20) / 1 INJECTION in 1 VIAL

Ingredients (1)

phentolamine mesylate (5 mg/1)

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": "4ecf4179-a773-4f75-a48b-a0b2c51facc2", "openfda": {"unii": ["Y7543E5K9T"], "rxcui": ["1361023"], "spl_set_id": ["e146c7ee-d2fa-433c-8768-0945e4ff0990"], "manufacturer_name": ["Precision Dose Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68094-101-20)  / 1 INJECTION in 1 VIAL", "package_ndc": "68094-101-20", "marketing_start_date": "20170715"}], "brand_name": "PHENTOLAMINE MESYLATE", "product_id": "68094-101_4ecf4179-a773-4f75-a48b-a0b2c51facc2", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "68094-101", "generic_name": "PHENTOLAMINE MESYLATE", "labeler_name": "Precision Dose Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PHENTOLAMINE MESYLATE", "active_ingredients": [{"name": "PHENTOLAMINE MESYLATE", "strength": "5 mg/1"}], "application_number": "ANDA207686", "marketing_category": "ANDA", "marketing_start_date": "20170715", "listing_expiration_date": "20261231"}