MedPath

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

432c3937-a4fe-4c92-8452-9ed2dd2cfc9a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 3, 2022

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

NDC Product Code71610-583
Application NumberANDA077927
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 3, 2022
Generic NameMeloxicam

INGREDIENTS (8)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MELOXICAMActive
Quantity: 7.5 mg in 1 1
Code: VG2QF83CGL
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Meloxicam - FDA Drug Approval Details