Fludrocortisone Acetate
Fludrocortisone Acetate Tablets, USP (0.1 mg) Rx only
Approved
Approval ID
96dbbf53-962b-49a4-a60d-91ae0b9fb9ff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 3, 2022
Manufacturers
FDA
Novitium Pharma LLC
DUNS: 080301870
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 Code70954-252
Application NumberANDA215279
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludrocortisone Acetate
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2022
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FLUDROCORTISONE ACETATEActive
Quantity: 0.1 mg in 1 1
Code: V47IF0PVH4
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT