NDC 63004-8710 – Acthar
Corticotropin 80 [USP'U]/mL · Injection · Intramuscular, Subcutaneous
Product NDC63004-8710
Product details
- Brand name
- Acthar
- Generic name
- Repository Corticotropin
- Labeler
- Mallinckrodt ARD LLC
- Dosage form
- Injection
- Route
- Intramuscular, Subcutaneous
- Marketing category
- NDA · NDA008372
- Marketed since
- January 7, 2013
- Listing expires
- December 31, 2027
- Pharmacologic class
- Adrenocorticotropic Hormone
Active ingredients
- Corticotropin 80 [USP'U]/mL
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 63004-8710-1 | 1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-1) / 5 mL in 1 VIAL, MULTI-DOSE | Jan 7, 2013 |
| 63004-8710-2 sample | 1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-2) / 5 mL in 1 VIAL, MULTI-DOSE | Jan 7, 2013 |
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
- 63004-8711 Corticotropin 80 [USP'U]/mL · Injection · Mallinckrodt ARD LLC
- 63004-8712 Corticotropin 40 [USP'U]/.5mL · Injection · Mallinckrodt ARD LLC