Prescription drug · NDA
Acthar (Repository corticotropin) NDC 63004-8710
Corticotropin 80 [USP'U]/mL · Injection · Intramuscular, Subcutaneous · Mallinckrodt ARD LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63004-8710-1 | 63004871001 | 1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-1) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Jan 7, 2013 | |
| 63004-8710-2 | 63004871002 | 1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-2) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Jan 7, 2013 · Sample package |
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
- Intramuscular, Subcutaneous
- Labeler
- Mallinckrodt ARD LLCNDC labeler code 63004
- 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 63004-8710_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
N463004871001followed by a unit qualifier and the quantityPackage 63004-8710-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 63004-8710
- What is NDC 63004-8710?
- 63004-8710 is the product NDC for Acthar (repository corticotropin), Corticotropin 80 [USP'U]/mL injection, listed with the FDA by Mallinckrodt ARD LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acthar (Repository Corticotropin).
- What is the active ingredient?
- Corticotropin.
- Who is the labeler?
- Mallinckrodt ARD LLC, NDC labeler code 63004. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acthar?
- 2 other product NDCs are listed under this name. See all Acthar NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acthar products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Actharrepository corticotropin | Corticotropin 80 [USP'U]/mL | InjectionSubcutaneous | Mallinckrodt ARD LLC | 63004-8711 | 63004-8711-04 |
| Actharrepository corticotropin | Corticotropin 40 [USP'U]/.5mL | InjectionSubcutaneous | Mallinckrodt ARD LLC | 63004-8712 | 63004-8712-04 |
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 | InjectionSubcutaneous | Mallinckrodt ARD LLC | 63004-8711 |
| Actharrepository corticotropin | Corticotropin 40 [USP'U]/.5mL | InjectionSubcutaneous | Mallinckrodt ARD LLC | 63004-8712 |