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
NDC Product Code63004-8710
Application NumberNDA008372
Marketing CategoryC73594
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Effective DateJune 30, 2023
Generic NameRepository Corticotropin
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