Fludrocortisone Acetate
Fludrocortisone Acetate Tablets USP
Approved
Approval ID
f5cffa20-9a22-43c5-9e89-3225852c2dfa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2019
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
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 Code0555-0997
Application NumberANDA040425
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludrocortisone Acetate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2019
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FLUDROCORTISONE ACETATEActive
Quantity: 0.1 mg in 1 1
Code: V47IF0PVH4
Classification: ACTIB
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT