Purified Cortrophin Gel
PURIFIED CORTROPHIN GEL (Repository Corticotropin Injection USP) Rx only
Approved
Approval ID
f27544ee-a0e2-4d84-b193-1c9efdf9e34c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2023
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
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 Code62559-860
Application NumberNDA008975
Product Classification
M
Marketing Category
C73594
G
Generic Name
Repository Corticotropin
Product Specifications
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Effective DateJune 21, 2023
FDA Product Classification
INGREDIENTS (6)
CORTICOTROPINActive
Quantity: 80 [USP'U] in 1 mL
Code: K0U68Q2TXA
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT