NDC Package 17478-538-02 Orphenadrine Citrate

Injection Intramuscular; Intravenous - View Billable Units, 11-Digit Format, RxNorm

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:
17478-538-02
Package Description:
10 VIAL in 1 CARTON / 2 mL in 1 VIAL
Product Code:
Proprietary Name:
Orphenadrine Citrate
Non-Proprietary Name:
Orphenadrine Citrate
Substance Name:
Orphenadrine Citrate
Usage Information:
Orphenadrine is used to treat muscle spasms/pain. It is usually used along with rest, physical therapy, and other treatment.
11-Digit NDC Billing Format:
17478053802
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 994541 - orphenadrine citrate 60 MG in 2 ML Injection
  • RxCUI: 994541 - 2 ML orphenadrine citrate 30 MG/ML Injection
  • RxCUI: 994541 - orphenadrine citrate 60 MG per 2 ML Injection
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Akorn
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA040484
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-17-2006
    End Marketing Date:
    10-31-2024
    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.

    Frequently Asked Questions

    What is NDC 17478-538-02?

    The NDC Packaged Code 17478-538-02 is assigned to a package of 10 vial in 1 carton / 2 ml in 1 vial of Orphenadrine Citrate, a human prescription drug labeled by Akorn. The product's dosage form is injection and is administered via intramuscular; intravenous form.

    Is NDC 17478-538 included in the NDC Directory?

    Yes, Orphenadrine Citrate with product code 17478-538 is active and included in the NDC Directory. The product was first marketed by Akorn on October 17, 2006.

    What is the NDC billing unit for package 17478-538-02?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 17478-538-02?

    The 11-digit format is 17478053802. 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
    5-3-217478-538-025-4-217478-0538-02