Acthar Injection
NDC Package 63004-8710-1

11-digit billing NDC: 63004871001 · Billing unit: ML · 5 ML per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Acthar (repository corticotropin) injection is dosage should be individualized according to the disease under treatment and the general medical condition of each patient. This formulation utilizes a injection delivery system. Marketed by Keenova Ard Llc, this product is identified by NDC 63004-8710 and is authorized under FDA application NDA008372.

Identification & Billing

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
11-Digit Billing Format
63004871001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
5 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Acthar
Non-Proprietary Name
Repository Corticotropin
Substance Name
Corticotropin
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • 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
Usage Information
Dosage should be individualized according to the disease under treatment and the general medical condition of each patient. Frequency and dose of the drug should be determined by considering severity of the disease and the initial response of the patient.The usual dose of Acthar Gel is 40 to 80 units given intramuscularly or subcutaneously every 24 to 72 hours.Although drug dependence does not occur, sudden withdrawal of Acthar Gel after prolonged use may lead to adrenal insufficiency or recurrent symptoms which make it difficult to stop the treatment. It may be necessary to taper the dose and increase the injection interval to gradually discontinue the medication.

Regulatory & Marketing

Labeler Name
Keenova Ard Llc
Product Type
Human Prescription Drug
FDA Application #
NDA008372
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-07-2013
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0801
Source: ASP
Inj. acthar gel to 40 units
HCPCS Dosage UP TO 40 UNITS
Units / Pkg 10

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63004-8710). Click a package code to view its specific billing and regulatory data.

63004-8710-2
1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63004-8710-1 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 5 ml in 1 vial, multi-dose of Acthar, a human prescription drug labeled by Keenova Ard Llc. This product is billed per "ML" milliliter and contains an estimated amount of 5 billable units per package. This injection is formulated for intramuscular; subcutaneous use and contains corticotropin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Keenova Ard Llc on January 07, 2013. The current certification is valid through December 31, 2027.

How is this Keenova Ard Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63004871001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 5 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
63004-8710-1
11-Digit CMS (5-4-2)
63004-8710-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.