Source: FDA, National Drug Code (US) Revision Year: 2021
Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides. The Acthar Gel manufacturing process converts the initial porcine pituitary extract with low ACTH content into a mixture having modified porcine ACTH and other related peptide analogs solubilized in gelatin. A major component in the formulated complex mixture is N-25 deamidated porcine ACTH (1-39).
Acthar Gel is supplied as a sterile preparation in 16% gelatin to provide a prolonged release after intramuscular or subcutaneous injection. Acthar Gel also contains 0.5% phenol, not more than 0.1% cysteine (added), sodium hydroxide and/or acetic acid to adjust pH and water for injection.
| Dosage Forms and Strengths |
|---|
|
5 mL multi-dose vial containing 80 USP Units per mL. |
| How Supplied |
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Acthar Gel (repository corticotropin injection) is supplied as 5 mL multi-dose vial (NDC 63004-8710-1) containing 80 USP Units per mL. Acthar Gel (repository corticotropin injection) should be warmed to room temperature before using. Do not over pressurize the vial prior to withdrawing the product. Manufactured for: Mallinckrodt ARD LLC., Bedminster, NJ 07921, USA |
| Drug | Countries | |
|---|---|---|
| ACTHAR | United Kingdom, United States |
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