Prescription drug · NDA
Acthar (repository corticotropin) NDC 63004-8711
Corticotropin 80 [USP'U]/mL · Injection · Subcutaneous · Mallinckrodt ARD LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63004-8711-4 | 63004871104 | 4 TRAY in 1 CARTON (63004-8711-4) / 1 SYRINGE in 1 TRAY (63004-8711-1) / 1 mL in 1 SYRINGEMarketed from Feb 29, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Acthar
- Generic name (nonproprietary)
- repository corticotropin
- Active ingredients
- Corticotropin — 80 [USP'U]/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Mallinckrodt ARD LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 008372
- Marketing start
- Listing expires
- Other FDA classes
- Adrenocorticotropic Hormone (Chemical structure)
- Identifiers
- Product ID 63004-8711_c63a790c-ec8a-4037-bbd3-cfe75cdd81abSPL ID c63a790c-ec8a-4037-bbd3-cfe75cdd81abSPL set ID 7b48ddec-e815-45f4-9ca0-5c0daaf56f30RxCUI 309541, 1040025, 2685293, 2685296, 2685298, 2685299UNII K0U68Q2TXAUPC 0363004871213
- Pharmacologic class
- Adrenocorticotropic Hormone
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N463004871104followed by a unit qualifier and the quantityPackage 63004-8711-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age. ( 1.1 ) Acthar Gel is indicated for the treatment of exacerbations of multiple sclerosis in adults. ( 1.2 ) Acthar Gel may be used for the following disorders and diseases: rheumatic ( 1.3 ); collagen ( 1.4 ); dermatologic ( 1.5 ); allergic states ( 1.6 ); ophthalmic ( 1.7 ); respiratory ( 1.8 ); and edematous state. ( 1.9 ) 1.1 Infantile Spasms Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age. 1.2 Multiple Sclerosis Acthar Gel is indicated for the treatment of acute exacerbations of multiple sclero…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 008372
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Actharrepository corticotropin | Corticotropin 80 [USP'U]/mL | InjectionIntramuscular, Subcutaneous | Mallinckrodt ARD LLC | 63004-8710 |
| Actharrepository corticotropin | Corticotropin 40 [USP'U]/.5mL | InjectionSubcutaneous | Mallinckrodt ARD LLC | 63004-8712 |