Acthar
- Product NDC
- 63004-8711
- 11-digit product format
- 630048711
- Labeler code
- 63004
- Product ID
- 63004-8711_f7c33d57-62a6-4791-8d3b-f81ac974ef3c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- repository corticotropin
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Mallinckrodt ARD LLC
- Application
- NDA008372
- Marketing category
- NDA
- Marketing start
- 2024-02-29
- Substance
- CORTICOTROPIN
- Active strength
- 80 [USP'U]/mL
- Pharmacologic classes
- Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| K0U68Q2TXA | CORTICOTROPIN | 12427-33-7 | CORTICOTROPIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63004-8711-4 | 63004871104 | 4 TRAY in 1 CARTON (63004-8711-4) / 1 SYRINGE in 1 TRAY (63004-8711-1) / 1 mL in 1 SYRINGE | 4 tray | 2024-02-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Acthar | Mallinckrodt ARD LLC | 2025-12-05 | HUMAN PRESCRIPTION DRUG LABEL | 28 |
| Acthar | Mallinckrodt ARD LLC | 2025-05-19 | HUMAN PRESCRIPTION DRUG LABEL | 26 |