Dexamethasone
DEXAMETHASONE ELIXIR, USP
Approved
Approval ID
7cf5c17c-a80b-4547-83b2-0d53e2b933f7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 3, 2023
Manufacturers
FDA
Rising Pharma Holdings, Inc.
DUNS: 116880195
Products 1
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 Code64980-509
Application NumberANDA090891
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 3, 2023
FDA Product Classification
INGREDIENTS (9)
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
DexamethasoneActive
Quantity: 0.5 mg in 5 mL
Code: 7S5I7G3JQL
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT