Meloxicam
These highlights do not include all the information needed to use MELOXICAM TABLETS USP safely and effectively. See full prescribing information for MELOXICAM TABLETS USP. MELOXICAM Tablets USP, for oral useInitial U.S. Approval: 2000
Approved
Approval ID
dfaac71c-dcc5-4b57-bf3b-616fccab96de
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 19, 2018
Manufacturers
FDA
Exelan Pharmaceuticals Inc.
DUNS: 967795266
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 Code76282-153
Application NumberANDA077927
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meloxicam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 17, 2023
FDA Product Classification
INGREDIENTS (8)
MELOXICAMActive
Quantity: 15 mg in 1 1
Code: VG2QF83CGL
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Meloxicam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-152
Application NumberANDA077927
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meloxicam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 17, 2023
FDA Product Classification
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MELOXICAMActive
Quantity: 7.5 mg in 1 1
Code: VG2QF83CGL
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT