Meloxicam
These highlights do not include all the information needed to use meloxicam oral suspension safely and effectively. See full prescribing information for meloxicam oral suspension. Meloxicam oral suspension Initial U.S. Approval: 2004
Approved
Approval ID
55af77dd-2abc-49a6-990c-399d5a5e7a91
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2024
Manufacturers
FDA
Emerald Therapeutics, LLC
DUNS: 116948577
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MELOXICAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72919-124
Application NumberNDA021530
Product Classification
M
Marketing Category
C73605
G
Generic Name
MELOXICAM
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2024
FDA Product Classification
INGREDIENTS (11)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MELOXICAMActive
Quantity: 7.5 mg in 5 mL
Code: VG2QF83CGL
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT