Dexamethasone
Approved
Approval ID
2dc5ea8d-82bf-40e1-b1cc-bee6bef2b62a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 25, 2019
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-0090
Application NumberANDA088238
Product Classification
M
Marketing Category
C73584
G
Generic Name
dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 4, 2018
FDA Product Classification
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DEXAMETHASONEActive
Quantity: 4 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-0087
Application NumberANDA088160
Product Classification
M
Marketing Category
C73584
G
Generic Name
dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 4, 2018
FDA Product Classification
INGREDIENTS (8)
DEXAMETHASONEActive
Quantity: 0.75 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT