Dexamethasone
Dexamethasone Tablets, USP
Approved
Approval ID
3e485ce7-a865-45b1-96c1-cdeed9ec40e0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 17, 2015
Manufacturers
FDA
Blenheim Pharmacal, Inc.
DUNS: 171434587
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 Code10544-212
Application NumberANDA088238
Product Classification
M
Marketing Category
C73584
G
Generic Name
dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 17, 2015
FDA Product Classification
INGREDIENTS (6)
DEXAMETHASONEActive
Quantity: 4 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10544-211
Application NumberANDA088237
Product Classification
M
Marketing Category
C73584
G
Generic Name
dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 17, 2015
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
DEXAMETHASONEActive
Quantity: 1.5 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT