FLUDROCORTISONE ACETATE
Fludrocortisone Acetate Tablets USP 0.1 mg
Approved
Approval ID
2cd3965d-cab9-a97c-db61-7d03ced154f3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
AvPAK
DUNS: 832926666
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FLUDROCORTISONE ACETATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50268-330
Application NumberANDA040431
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUDROCORTISONE ACETATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FLUDROCORTISONE ACETATEActive
Quantity: 0.1 mg in 1 1
Code: V47IF0PVH4
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT