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
NDC Product Code70954-252
Application NumberANDA215279
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 3, 2022
Generic NameFludrocortisone Acetate
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