Cortisone Acetate
Rx Only
Approved
Approval ID
cc158d11-f356-4696-8b73-5d2681dcbcf2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cortisone Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-173
Application NumberANDA080694
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cortisone Acetate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CORTISONE ACETATEActive
Quantity: 25 mg in 1 1
Code: 883WKN7W8X
Classification: ACTIB