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  5. NDC Package Code: 63004-8710-1 Acthar

NDC Package 63004-8710-1 Acthar

Repository Corticotropin Injection Intramuscular; Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. 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:
63004-8710-1
Package Description:
1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE
Product Code:
63004-8710
Proprietary Name:
Acthar
Non-Proprietary Name:
Repository Corticotropin
Substance Name:
Corticotropin
Usage Information:
This medication is used to treat a certain type of seizure in children (infantile spasms). This medication is also used to treat conditions such as multiple sclerosis, arthritis, lupus, eye conditions, skin/kidney/lung diseases, and immune system disorders. It decreases your immune system's response to various diseases to reduce symptoms such as swelling, pain, and allergic-type reactions. Corticotropin is a hormone.
11-Digit NDC Billing Format:
63004871001
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1040025 - Acthar H.P. Gel 80 UNT/ML Injectable Solution
  • RxCUI: 1040025 - corticotropin 80 UNT/ML Injectable Solution [Acthar]
  • RxCUI: 1040025 - Acthar 80 UNT/ML Injectable Solution
  • RxCUI: 1040025 - Acthar Gel 80 UNT/ML Injectable Solution
  • RxCUI: 309541 - corticotropin 80 UNT/ML Injectable Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mallinckrodt Ard Llc
    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.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • CORTICOTROPIN 80 [USP'U]/mL
    • Pharmacologic Class(es):
  • Adrenocorticotropic Hormone - [CS]
  • Adrenocorticotropic Hormone - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA008372
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    01-07-2013
    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.

    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 63004-8710-1 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    63004871001J0801Inj. acthar gel to 40 unitsUP TO 40 UNITS511010

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    63004-8710-21 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63004-8710-1?

    The NDC Packaged Code 63004-8710-1 is assigned to a package of 1 vial, multi-dose in 1 carton / 5 ml in 1 vial, multi-dose of Acthar, a human prescription drug labeled by Mallinckrodt Ard Llc. The product's dosage form is injection and is administered via intramuscular; subcutaneous form.

    Is NDC 63004-8710 included in the NDC Directory?

    Yes, Acthar with product code 63004-8710 is active and included in the NDC Directory. The product was first marketed by Mallinckrodt Ard Llc on January 07, 2013 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 NDC billing unit for package 63004-8710-1?

    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 63004-8710-1?

    The 11-digit format is 63004871001. 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 5-4-1 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
    5-4-163004-8710-15-4-263004-8710-01