Dexamethasone
Dexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP ™ (Concentrate)
Approved
Approval ID
a7380e36-e274-4d03-b172-869b72645f7b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 23, 2018
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
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 Code53217-374
Application NumberANDA084612
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2018
FDA Product Classification
INGREDIENTS (8)
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
DEXAMETHASONEActive
Quantity: 4 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT