Dexamethasone
DEXAMETHASONE TABLETS, USP
Approved
Approval ID
9ab26af9-8196-e3d3-76a3-75227fd4e1c3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
Alvogen Inc.
DUNS: 008057330
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dexamethasone
PRODUCT DETAILS
NDC Product Code47781-914
Application NumberANDA088481
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 31, 2021
Generic Namedexamethasone
INGREDIENTS (6)
dexamethasoneActive
Quantity: 4 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
dexamethasone
PRODUCT DETAILS
NDC Product Code47781-916
Application NumberANDA088481
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 31, 2021
Generic Namedexamethasone
INGREDIENTS (6)
dexamethasoneActive
Quantity: 6 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT