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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, USPInitial U.S. Approval: 2000

Approved
Approval ID

87c6d3e2-7c66-479b-abe8-551cb8913921

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 31, 2013

Manufacturers
FDA

Blenheim Pharmacal, Inc.

DUNS: 171434587

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 Code10544-090
Application NumberANDA077918
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meloxicam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2013
FDA Product Classification

INGREDIENTS (8)

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LactoseInactive
Code: J2B2A4N98G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Sodium CitrateInactive
Code: 1Q73Q2JULR
Classification: IACT
MeloxicamActive
Quantity: 7.5 mg in 1 1
Code: VG2QF83CGL
Classification: ACTIB
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Povidone K30Inactive
Code: U725QWY32X
Classification: IACT

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Meloxicam - FDA Drug Approval Details