Fludrocortisone Acetate
FLUDROCORTISONE ACETATE TABLETS, USP(0.1 mg)
Approved
Approval ID
3c007f9a-4cd5-4e74-a633-d55dde1fe903
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2020
Manufacturers
FDA
NCS HealthCare of KY, Inc dba Vangard Labs
DUNS: 050052943
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 Code0615-6562
Application NumberANDA040431
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUDROCORTISONE ACETATE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2020
FDA Product Classification
INGREDIENTS (5)
FLUDROCORTISONE ACETATEActive
Quantity: 0.1 mg in 1 1
Code: V47IF0PVH4
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT