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  5. NDC Package Code: 83368-075-30 Ryzumvi

NDC Package 83368-075-30 Ryzumvi

Phentolamine Mesylate Solution/ Drops Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
83368-075-30
Package Description:
6 POUCH in 1 CARTON / 5 VIAL, SINGLE-USE in 1 POUCH / 1 mL in 1 VIAL, SINGLE-USE
Product Code:
83368-075
Proprietary Name:
Ryzumvi
Non-Proprietary Name:
Phentolamine Mesylate
Substance Name:
Phentolamine Mesylate
Usage Information:
Ryzumvi is indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents.
11-Digit NDC Billing Format:
83368007530
NDC to RxNorm Crosswalk:
  • RxCUI: 2677793 - phentolamine 0.75 % Ophthalmic Solution
  • RxCUI: 2677793 - phentolamine 7.5 MG/ML Ophthalmic Solution
  • RxCUI: 2677793 - phentolamine 7.5 MG (as phentolamine mesylate 10 MG) per 1 ML Ophthalmic Solution
  • RxCUI: 2677798 - Ryzumvi 0.75 % Ophthalmic Solution
  • RxCUI: 2677798 - phentolamine 7.5 MG/ML Ophthalmic Solution [Ryzumvi]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Oyster Point Pharma, Inc.
    Dosage Form:
    Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
    Administration Route(s):
  • Ophthalmic - Administration to the external eye.
    • Active Ingredient(s):
  • PHENTOLAMINE MESYLATE 10 mg/mL
    • Pharmacologic Class(es):
  • Adrenergic alpha-Antagonists - [MoA] (Mechanism of Action)
  • alpha-Adrenergic Blocker - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA217064
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-25-2024
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 83368-075-30?

    The NDC Packaged Code 83368-075-30 is assigned to a package of 6 pouch in 1 carton / 5 vial, single-use in 1 pouch / 1 ml in 1 vial, single-use of Ryzumvi, a human prescription drug labeled by Oyster Point Pharma, Inc.. The product's dosage form is solution/ drops and is administered via ophthalmic form.

    Is NDC 83368-075 included in the NDC Directory?

    Yes, Ryzumvi with product code 83368-075 is active and included in the NDC Directory. The product was first marketed by Oyster Point Pharma, Inc. on March 25, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 83368-075-30?

    The 11-digit format is 83368007530. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-283368-075-305-4-283368-0075-30