meloxicam
These highlights do not include all the information needed to use MELOXICAM TABLETS safely and effectively. See full prescribing information for MELOXICAM TABLETS. MELOXICAM tablets, for oral use Initial U.S. Approval: 2000
Approved
Approval ID
10c3949c-0066-4b8a-8d35-937e1ce09bf8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 6, 2021
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code71610-580
Application NumberANDA077921
Product Classification
M
Marketing Category
C73584
G
Generic Name
meloxicam
Product Specifications
Route of AdministrationORAL
Effective DateAugust 6, 2021
FDA Product Classification
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MELOXICAMActive
Quantity: 15 mg in 1 1
Code: VG2QF83CGL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT