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  5. NDC Package Code: 70954-504-20 Selegiline Hydrochloride

NDC Package 70954-504-20 Selegiline Hydrochloride

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    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:
70954-504-20
Package Description:
1000 CAPSULE in 1 BOTTLE
Product Code:
70954-504
Proprietary Name:
Selegiline Hydrochloride
Non-Proprietary Name:
Selegiline Hydrochloride
Substance Name:
Selegiline Hydrochloride
Usage Information:
Selegiline hydrochloride capsules, USP are indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy. Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving   levodopa/carbidopa. Selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of 'off' time, and patient self-rating of treatment success. Beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous state).
11-Digit NDC Billing Format:
70954050420
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1000 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 859186 - selegiline HCl 5 MG Oral Capsule
  • RxCUI: 859186 - selegiline hydrochloride 5 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Novitium Pharma Llc
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • SELEGILINE HYDROCHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • Monoamine Oxidase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Monoamine Oxidase Inhibitors - [MoA] (Mechanism of Action)
  • Monoamine Oxidase Type B Inhibitor - [EPC] (Established Pharmacologic Class)
  • Monoamine Oxidase-B Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA075352
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-01-2021
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    70954-504-1060 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70954-504-20?

    The NDC Packaged Code 70954-504-20 is assigned to a package of 1000 capsule in 1 bottle of Selegiline Hydrochloride, a human prescription drug labeled by Novitium Pharma Llc. The product's dosage form is capsule and is administered via oral form.

    Is NDC 70954-504 included in the NDC Directory?

    Yes, Selegiline Hydrochloride with product code 70954-504 is active and included in the NDC Directory. The product was first marketed by Novitium Pharma Llc on April 01, 2021 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 70954-504-20?

    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 1000.

    What is the 11-digit format for NDC 70954-504-20?

    The 11-digit format is 70954050420. 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
    5-3-270954-504-205-4-270954-0504-20