NDC 63004-8711 – Acthar
Corticotropin 80 [USP'U]/mL · Injection · Subcutaneous
Product NDC63004-8711
Product details
- Brand name
- Acthar
- Generic name
- Repository corticotropin
- Labeler
- Mallinckrodt ARD LLC
- Dosage form
- Injection
- Route
- Subcutaneous
- Marketing category
- NDA · NDA008372
- Marketed since
- February 29, 2024
- Listing expires
- December 31, 2027
- Pharmacologic class
- Adrenocorticotropic Hormone
Active ingredients
- Corticotropin 80 [USP'U]/mL
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 63004-8711-4 | 4 TRAY in 1 CARTON (63004-8711-4) / 1 SYRINGE in 1 TRAY (63004-8711-1) / 1 mL in 1 SYRINGE | Feb 29, 2024 |
Recalls mentioning this NDC
- D-0803-2026 Sep 2, 2026 · Class II
Presence of particulate matter: glass and stopper piece - D-0340-2024 Feb 28, 2024 · Class II
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Other Acthar products
- 63004-8710 Corticotropin 80 [USP'U]/mL · Injection · Mallinckrodt ARD LLC
- 63004-8712 Corticotropin 40 [USP'U]/.5mL · Injection · Mallinckrodt ARD LLC