Dexamethasone
dexamethasone 4mg
Approved
Approval ID
674fd223-fd39-e608-e053-2991aa0a9bdc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2022
Manufacturers
FDA
RedPharm Drug
DUNS: 828374897
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 Code67296-0326
Application NumberANDA084612
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2022
FDA Product Classification
INGREDIENTS (8)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DEXAMETHASONEActive
Quantity: 4 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB