Dexamethasone
DEXAMETHASONE Tablets USP,DEXAMETHASONE Oral Solution,and DEXAMETHASONE Intensol ™ Oral Solution (Concentrate)
Approved
Approval ID
0372f916-0a26-4115-8075-2d575bfbc15e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2012
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-290
Application NumberANDA084613
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2009
FDA Product Classification
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
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT