Dexamethasone
Dexamethasone Tablets, USP Rx only
Approved
Approval ID
c4d1e578-a1d2-4d5e-8426-6b2c39f0d9bd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 26, 2023
Manufacturers
FDA
Preferred Pharmaceuticals, Inc.
DUNS: 791119022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexamethasone
PRODUCT DETAILS
NDC Product Code68788-8467
Application NumberANDA215604
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 26, 2023
Generic NameDexamethasone
INGREDIENTS (7)
DEXAMETHASONEActive
Quantity: 4 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT