Dexamethasone
Dexamethasone Tablets, USP 4mg and 6 mg Rx only
Approved
Approval ID
3166db4f-66a5-496a-a194-3cc01b7347d3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2023
Manufacturers
FDA
Bionpharma Inc.,
DUNS: 079637826
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 Code69452-277
Application NumberANDA217001
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DEXAMETHASONEActive
Quantity: 4 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
Dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69452-278
Application NumberANDA217001
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DEXAMETHASONEActive
Quantity: 6 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB