ELYXYB - celecoxib
These highlights do not include all the information needed to use ELYXYB safely and effectively. See full prescribing information for ELYXYB. ELYXYB (celecoxib) oral solution Initial U.S. Approval: 1998
Approved
Approval ID
c8a5de07-9f27-4a54-a885-8089f0307bd7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 20, 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.
celecoxib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69557-333
Application NumberNDA212157
Product Classification
M
Marketing Category
C73594
G
Generic Name
celecoxib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2023
FDA Product Classification
INGREDIENTS (15)
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
LAUROYL PEG-32 GLYCERIDESInactive
Code: H5ZC52369M
Classification: IACT
GLYCERYL MONOCAPRYLATEInactive
Code: TM2TZD4G4A
Classification: IACT
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
LEVOMENTHOLInactive
Code: BZ1R15MTK7
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26C
Classification: IACT
BANANAInactive
Code: 4AJZ4765R9
Classification: IACT
CELECOXIBActive
Quantity: 120 mg in 4.8 mL
Code: JCX84Q7J1L
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT