Meloxicam
These highlights do not include all the information needed to use MELOXICAM TABLETS safety and effectively. See full prescribing information for MELOXICAM TABLETS. MELOXICAM tablets, for oral use Initial U.S. Approval: 2000
Approved
Approval ID
06623222-188c-4ab1-976a-4cdb2037a709
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2019
Manufacturers
FDA
International Laboratories, LLC
DUNS: 023569924
Products 2
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 Code54458-965
Application NumberANDA077921
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meloxicam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2019
FDA Product Classification
INGREDIENTS (8)
MELOXICAMActive
Quantity: 7.5 mg in 1 1
Code: VG2QF83CGL
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Meloxicam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-964
Application NumberANDA077921
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meloxicam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2019
FDA Product Classification
INGREDIENTS (8)
MELOXICAMActive
Quantity: 15 mg in 1 1
Code: VG2QF83CGL
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT