oraverse

Generic: phentolamine mesylate

Labeler: septodont, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name oraverse
Generic Name phentolamine mesylate
Labeler septodont, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBMUCOSAL
Active Ingredients

phentolamine mesylate .235 mg/mL

Manufacturer
Septodont, Inc.

Identifiers & Regulatory

Product NDC 0362-0101
Product ID 0362-0101_f0465990-acce-46dc-9290-344dab1e4f2f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022159
Listing Expiration 2026-12-31
Marketing Start 2011-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03620101
Hyphenated Format 0362-0101

Supplemental Identifiers

RxCUI
1361019 1361021
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 oraverse (source: ndc)
Generic Name phentolamine mesylate (source: ndc)
Application Number NDA022159 (source: ndc)
Routes
SUBMUCOSAL
source: ndc

Resolved Composition

Strengths
  • .235 mg/mL
source: ndc
Packaging
  • 10 CARTRIDGE in 1 CARTON (0362-0101-10) / 1.7 mL in 1 CARTRIDGE
source: ndc

Packages (1)

0362-0101-10 10 CARTRIDGE in 1 CARTON (0362-0101-10) / 1.7 mL in 1 CARTRIDGE

Ingredients (1)

phentolamine mesylate (.235 mg/mL)

Linked Drug Pages (1)

Oraverse ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBMUCOSAL"], "spl_id": "f0465990-acce-46dc-9290-344dab1e4f2f", "openfda": {"unii": ["Y7543E5K9T"], "rxcui": ["1361019", "1361021"], "spl_set_id": ["4025cf98-ea87-4531-b0fc-6283c84f63f3"], "manufacturer_name": ["Septodont, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CARTRIDGE in 1 CARTON (0362-0101-10)  / 1.7 mL in 1 CARTRIDGE", "package_ndc": "0362-0101-10", "marketing_start_date": "20110601"}], "brand_name": "Oraverse", "product_id": "0362-0101_f0465990-acce-46dc-9290-344dab1e4f2f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "0362-0101", "generic_name": "Phentolamine Mesylate", "labeler_name": "Septodont, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oraverse", "active_ingredients": [{"name": "PHENTOLAMINE MESYLATE", "strength": ".235 mg/mL"}], "application_number": "NDA022159", "marketing_category": "NDA", "marketing_start_date": "20110601", "listing_expiration_date": "20261231"}