DEXAMETHASONE
Dexamethasone
Approved
Approval ID
3ff06262-4c6f-4423-99fa-b4d8191ea133
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 17, 2020
Manufacturers
FDA
Direct Rx
DUNS: 079254320
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 Code61919-269
Application NumberANDA088237
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 17, 2020
Generic NameDexamethasone
INGREDIENTS (7)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DEXAMETHASONEActive
Quantity: 1.5 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DEXAMETHASONE
PRODUCT DETAILS
NDC Product Code61919-827
Application NumberANDA084610
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 17, 2020
Generic NameDEXAMETHASONE
INGREDIENTS (8)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
DEXAMETHASONEActive
Quantity: 1.5 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB