Dexamethasone
Dexamethasone Elixir, USP
Approved
Approval ID
c6eb10d2-2251-482b-8a57-fea31c05bc7e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2018
Manufacturers
FDA
Morton Grove Pharmaceuticals, Inc.
DUNS: 801897505
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexamethasone
PRODUCT DETAILS
NDC Product Code60432-466
Application NumberANDA088254
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 21, 2018
Generic NameDexamethasone
INGREDIENTS (9)
DEXAMETHASONEActive
Quantity: 0.5 mg in 5 mL
Code: 7S5I7G3JQL
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT