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  5. NDC Package Code: 62935-163-60 Fensolvi

NDC Package 62935-163-60 Fensolvi

Leuprolide Acetate Injection, Suspension, Extended Release Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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:
62935-163-60
Package Description:
1 SYRINGE in 1 CARTON / .375 mL in 1 SYRINGE
Product Code:
62935-163
Proprietary Name:
Fensolvi
Non-Proprietary Name:
Leuprolide Acetate
Substance Name:
Leuprolide Acetate
Usage Information:
Leuprolide is used to treat advanced prostate cancer in men. It is not a cure. Most types of prostate cancer need the male hormone testosterone to grow and spread. Leuprolide works by reducing the amount of testosterone that the body makes. This helps slow or stop the growth of cancer cells and helps relieve symptoms such as painful/difficult urination. Talk to your doctor about the risks and benefits of treatment.
11-Digit NDC Billing Format:
62935016360
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2371773 - Fensolvi 45 MG in 0.375 ML (6 month) Prefilled Syringe
  • RxCUI: 2371773 - 0.375 ML leuprolide acetate 120 MG/ML Prefilled Syringe [Fensolvi]
  • RxCUI: 2371773 - 0.375 ML Fensolvi 120 MG/ML Prefilled Syringe
  • RxCUI: 2371773 - Fensolvi Every 6 Months 45 MG per 0.375 ML Prefilled Syringe
  • RxCUI: 752884 - leuprolide acetate 45 MG in 0.375 ML (6 month) Prefilled Syringe
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Tolmar Inc.
    Dosage Form:
    Injection, Suspension, Extended Release - A sterile preparation intended for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form).
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • LEUPROLIDE ACETATE 45 mg/.375mL
    • Pharmacologic Class(es):
  • Gonadotropin Releasing Hormone Receptor Agonist - [EPC] (Established Pharmacologic Class)
  • Gonadotropin Releasing Hormone Receptor Agonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA213150
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-06-2023
    Listing Expiration Date:
    12-31-2024
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 62935-163-60 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    62935016360J1951Inj fensolvi 0.25 mg0.25 MG11180180

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 62935-163-60?

    The NDC Packaged Code 62935-163-60 is assigned to a package of 1 syringe in 1 carton / .375 ml in 1 syringe of Fensolvi, a human prescription drug labeled by Tolmar Inc.. The product's dosage form is injection, suspension, extended release and is administered via subcutaneous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 62935-163 included in the NDC Directory?

    Yes, Fensolvi with product code 62935-163 is active and included in the NDC Directory. The product was first marketed by Tolmar Inc. on March 06, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 62935-163-60?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 62935-163-60?

    The 11-digit format is 62935016360. 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
    5-3-262935-163-605-4-262935-0163-60