dexamethasone
Dexamethasone Tablets, USP (4 mg and 6 mg) Rx Only
Approved
Approval ID
ac71f888-c83a-46a5-921c-1ebdf6cfadc1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 2
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 Code60219-2043
Application NumberANDA215106
Product Classification
M
Marketing Category
C73584
G
Generic Name
dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2023
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
DEXAMETHASONEActive
Quantity: 4 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60219-2044
Application NumberANDA215106
Product Classification
M
Marketing Category
C73584
G
Generic Name
dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2023
FDA Product Classification
INGREDIENTS (5)
DEXAMETHASONEActive
Quantity: 6 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT