MedPath

meloxicam

These highlights do not include all the information needed to use meloxicam safely and effectively. See full prescribing information for meloxicam. meloxicam (meloxicam) TABLET for ORAL use.Initial U.S. Approval: 2000

Approved
Approval ID

02f9696c-87d0-4f2b-a90f-d04b3ba767b1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 30, 2013

Manufacturers
FDA

New Horizon Rx Group, LLC

DUNS: 056256127

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 Code58517-260
Application NumberANDA077927
Product Classification
M
Marketing Category
C73584
G
Generic Name
meloxicam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2013
FDA Product Classification

INGREDIENTS (8)

MELOXICAMActive
Quantity: 15 mg in 1 1
Code: VG2QF83CGL
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.