Dexamethasone
Dexamethasone Tablets, USP Rx only
Approved
Approval ID
348f5a56-978d-4272-e063-6294a90afdb6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Advanced Rx of Tennessee, LLC
DUNS: 117023142
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80425-0515
Application NumberANDA217001
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (5)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
DEXAMETHASONEActive
Quantity: 4 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT