Acthar
These highlights do not include all the information needed to use ACTHAR® GEL safely and effectively. See full prescribing information for ACTHAR GEL. ACTHAR GEL (repository corticotropin injection), for intramuscular or subcutaneous use. Initial U.S. Approval: 1952
Approved
Approval ID
7b48ddec-e815-45f4-9ca0-5c0daaf56f30
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2023
Manufacturers
FDA
Mallinckrodt ARD LLC
DUNS: 625130828
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Repository Corticotropin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63004-8710
Application NumberNDA008372
Product Classification
M
Marketing Category
C73594
G
Generic Name
Repository Corticotropin
Product Specifications
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Effective DateJune 30, 2023
FDA Product Classification
INGREDIENTS (7)
CORTICOTROPINActive
Quantity: 80 [USP'U] in 1 mL
Code: K0U68Q2TXA
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
CYSTEINEInactive
Code: K848JZ4886
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT