Dexamethasone
DEXAMETHASONE TABLETS, USP
Approved
Approval ID
f3d1f760-562f-09b2-e053-2a95a90a7f42
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 3, 2023
Manufacturers
FDA
Redpharm Drug, Inc.
DUNS: 828374897
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 Code67296-1837
Application NumberANDA088481
Product Classification
M
Marketing Category
C73584
G
Generic Name
dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 3, 2023
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
DEXAMETHASONEActive
Quantity: 4 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT