Acthar Injection
NDC Package 63004-8710-2
Package Information
Acthar (repository corticotropin) injection is a medication used to treat a certain type of seizure in children (infantile spasms). This formulation utilizes a injection delivery system. Marketed by Mallinckrodt Ard Llc, this product is identified by NDC 63004-8710 and is authorized under FDA application NDA008372.
Identification & Billing
- 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: 2685293 - corticotropin 80 UNT in 1 ML Prefilled Self-Controlled Injector
Clinical Specifications
- Intramuscular - Administration within a muscle.
- Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Regulatory & Marketing
Hierarchy Structure
- 63004 - Mallinckrodt Ard Llc
- 63004-8710 - Acthar
- 63004-8710-2 - 1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE
- 63004-8710 - Acthar
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.
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.
* 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 63004-8710-2 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 Mallinckrodt Ard Llc. 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 Mallinckrodt Ard Llc on January 07, 2013. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
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.
How is this Mallinckrodt Ard Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 63004871002. 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
