Gloperba
These highlights do not include all the information needed to use GLOPERBA safely and effectively. See full prescribing information for GLOPERBA. GLOPERBA (colchicine) Oral Solution Initial U.S. Approval: 1961
Approved
Approval ID
467cd83f-d695-4040-9434-10e80b4271da
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2023
Manufacturers
FDA
Scilex Pharmaceuticals, Inc.
DUNS: 078286225
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Colchicine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69557-222
Application NumberNDA210942
Product Classification
M
Marketing Category
C73594
G
Generic Name
Colchicine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2022
FDA Product Classification
INGREDIENTS (11)
ColchicineActive
Quantity: 0.6 mg in 5 mL
Code: SML2Y3J35T
Classification: ACTIB
benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
sucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CherryInactive
Code: BUC5I9595W
Classification: IACT