Dexamethasone
Dexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP ™ (Concentrate)
Approved
Approval ID
a9fd2013-0797-4ec4-82c5-07d282522625
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 17, 2020
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexamethasone
PRODUCT DETAILS
NDC Product Code63629-7850
Application NumberANDA088306
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 27, 2020
Generic NameDexamethasone
INGREDIENTS (6)
DEXAMETHASONEActive
Quantity: 1 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Dexamethasone
PRODUCT DETAILS
NDC Product Code63629-4129
Application NumberANDA084613
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 27, 2020
Generic NameDexamethasone
INGREDIENTS (6)
DEXAMETHASONEActive
Quantity: 0.75 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Dexamethasone
PRODUCT DETAILS
NDC Product Code63629-7806
Application NumberANDA088316
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 27, 2020
Generic NameDexamethasone
INGREDIENTS (6)
DEXAMETHASONEActive
Quantity: 6 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT