Dexamethasone Intensol
Dexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP ™ (Concentrate)
Approved
Approval ID
a817ab46-54ec-4e3f-886b-04ce6ac1caf9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 6, 2016
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexamethasone Intensol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68151-5026
Application NumberANDA088252
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone Intensol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2016
FDA Product Classification
INGREDIENTS (7)
DEXAMETHASONEActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT