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Meloxicam 15 mg Tablet, 90-count — NDC 43353-979-60 (Billing 43353-0979-60)

by Aphena Pharma Solutions - Tennessee, LLC · 90 TABLET in 1 BOTTLE, PLASTIC

This is a package of 90 tablets of Meloxicam 15 mg Tablet from Aphena Pharma Solutions - Tennessee, LLC, marketed since Jun 2010 and currently FDA-listed.

NDC 43353-0979-60
🏷️ FDA NDC (as labeled) 43353-979-60 billing pads the product segment with a zero
This package
Contains90-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.0985/unit — full pricing hub ↓
Product page 43353-0979-30 Also comes in: 30 tablets 43353-979-30
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43353-979-60
Product NDC 43353-979
11-digit billing NDC 43353097960
NCPDP billing unit EA — each (per item)
RxCUI 152695
UNII VG2QF83CGL
Application # ANDA077918
SPL Set ID 2a29daa9-74e5-4ed6-b5f1-ce04dc411b26
Established class (EPC) Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-06-30
Route ORAL
Dosage form TABLET
Substance MELOXICAM
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 66100052000330
GPI class Meloxicam
GCN Seq No 029157
GCN 31662
HICL code 012181
Ingredient (HICL) Meloxicam
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S2
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On Joints
HIC3 code S2B
Therapeutic class — specific (HIC3) Nsaids, Cyclooxygenase Inhibitor Type Analgesics
AHFS code 28:08.04.04
AHFS class Reversible Cox-1/Cox-2 Inhibitors
FDB label name MELOXICAM 15 MG TABLET
FDB brand name Meloxicam
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 029157
  • GCN: 31662
  • GPI-14 (Medi-Span): 66100052000330
  • HICL (First Databank): 012181
  • AHFS class code: 28:08.04.04
  • RxCUI (RxNorm): 152695
Why two NDCs? The FDA registers this code as 43353-979-60 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 43353-0979-60. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Amides, Oxicams
How it works Cyclooxygenase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name MELOXICAM 15 MG TABLET Ingredient Meloxicam
📗 Our plain-language guide HelloPharmacist
  • Meloxicam is an NSAID that eases pain and swelling from osteoarthritis and rheumatoid arthritis. Some forms are also used for juvenile rheumatoid arthritis. The injection forms, Qa...
  • Oral meloxicam is usually taken by mouth once a day, with or without food. If you use the suspension, shake it gently first. Take it at the lowest effective dose for as short a tim...
  • The most common ones are diarrhea, indigestion, nausea, belly pain, headache, flu-like symptoms and upper respiratory infections. Some people notice swelling. Let me know if these...
  • Get help for chest pain, shortness of breath, weakness on one side or slurred speech. Also call for black or bloody stools, vomiting blood, a rash, yellow skin or eyes, or swelling...
📖 Read our full Meloxicam guide →
1
Nutrient depletion considerations

Meloxicam may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Meloxicam nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.0985 $8.87 / 90 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
43353-0979-30 43353-979-30 Main listing 30 TABLET in 1 BOTTLE, PLASTIC 2020-04-02 — Active
43353-0979-60 You're viewing this 90 TABLET in 1 BOTTLE, PLASTIC 2014-11-06 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 90-count package — 90 tablet in 1 bottle, plastic.
How does this package differ from NDC 43353-0979-30?
Both are Meloxicam 15 mg Tablet — the drug itself is identical. This page's package is the 90-count one, while NDC 43353-0979-30 is the 30 tablets package.
What NDC number is used to bill for this package of Meloxicam 15 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Meloxicam 15 mg 11788-0047-01 AiPing 100 tablets $0.018 AB Availability likely —
meloxicam 15 mg 29300-0125-01 Unichem 100 tablets $0.018 AB Availability likely —
Meloxicam 15 mg 50268-0526-15 AvPAK 50 tablets $0.018 AB Availability likely —
Meloxicam 15 mg 60687-0199-01 American 100 tablets $0.018 AB Availability likely —
Meloxicam 15 mg 61442-0127-10 Carlsbad 1000 tablets $0.018 AB Availability likely —
Meloxicam 15 mg 62135-0716-18 Chartwell 180 tablets $0.018 AB Availability likely —
meloxicam 15 mg 68382-0051-01 Zydus 100 tablets $0.018 AB Availability likely —
Meloxicam 15 mg 69097-0159-07 Cipla 100 tablets $0.018 AB Availability likely —
Meloxicam 15 mg 76282-0153-01 Exelan 100 tablets $0.018 AB Availability likely —
meloxicam 15 mg 82009-0130-05 Quallent 500 tablets $0.018 AB Availability likely —
Meloxicam 15 mg 00615-8124-39 NCS 30 tablets — AB FDA listed —
Meloxicam 15 mg 11788-0099-00 AiPing 83000 tablets — AB FDA listed —
Meloxicam 15 mg 31722-0227-01 Camber 100 tablets — AB FDA listed —
meloxicam 15 mg 42708-0007-30 QPharma, 30 tablets — AB FDA listed —
Meloxicam 15 mg 43063-0396-07 PD-Rx 7 tablets — AB FDA listed —
meloxicam 15 mg 43063-0401-06 PD-Rx 6 tablets — AB FDA listed —
Meloxicam 15 mgthis 43353-0979-60 Aphena 90 tablets — AB FDA listed —
Meloxicam 15 mg 49999-0869-15 Quality 15 tablets — AB Discontinued —
meloxicam 15 mg 50090-0986-00 A-S 7 tablets — AB FDA listed —
meloxicam 15 mg 50090-4896-00 A-S 90 tablets — AB FDA listed —
meloxicam 15 mg 50090-5339-00 A-S 7 tablets — AB FDA listed —
meloxicam 15 mg 50090-5340-00 A-S 90 tablets — AB FDA listed —
Meloxicam 15 mg 50090-6671-00 A-S 7 tablets — AB FDA listed —
Meloxicam 15 mg 50090-6672-00 A-S 90 tablets — AB FDA listed —
Meloxicam 15 mg 51407-0611-10 Golden 1000 tablets — AB FDA listed —
Meloxicam 15 mg 51655-0571-26 Northwind 90 tablets — AB FDA listed —
meloxicam 15 mg 51655-0577-26 Northwind 90 tablets — AB FDA listed —
Meloxicam 15 mg 53225-3015-01 Terrain 30 tablets — AB FDA listed —
meloxicam 15 mg 60760-0419-07 St. 7 tablets — AB FDA listed —
Meloxicam 15 mg 60760-0653-07 St. 7 tablets — AB FDA listed —
Meloxicam 15 mg 61919-0469-30 Direct 30 tablets — AB FDA listed —
meloxicam 15 mg 63187-0083-10 Proficient 10 tablets — AB FDA listed —
Meloxicam 15 mg 63629-2019-01 Bryant 1000 tablets — AB FDA listed —
meloxicam 15 mg 63629-3328-00 Bryant 20 tablets — AB FDA listed —
meloxicam 15 mg 65841-0051-01 Zydus 100 tablets — AB FDA listed —
Meloxicam 15 mg 65862-0098-01 Aurobindo 100 tablets — AB FDA listed —
meloxicam 15 mg 67046-0891-03 Coupler 30 tablets — AB FDA listed —
Meloxicam 15 mg 67296-1317-03 Redpharm 30 tablets — AB Discontinued —
meloxicam 15 mg 68071-1993-03 NuCare 30 tablets — AB FDA listed —
Meloxicam 15 mg 68071-2184-03 NuCare 30 tablets — AB FDA listed —
meloxicam 15 mg 68071-3030-05 NuCare 15 tablets — AB FDA listed —
meloxicam 15 mg 68788-7904-01 Preferred 15 tablets — AB FDA listed —
meloxicam 15 mg 68788-8801-00 Preferred 100 tablets — AB FDA listed —
Meloxicam 15 mg 70518-0200-00 REMEDYREPACK 30 tablets — AB FDA listed —
meloxicam 15 mg 70518-0394-00 REMEDYREPACK 30 tablets — AB FDA listed —
Meloxicam 15 mg 70518-1630-02 REMEDYREPACK 60 tablets — AB Discontinued —
meloxicam 15 mg 70518-1828-02 REMEDYREPACK 100 tablets — AB Discontinued —
Meloxicam 15 mg 71205-0924-00 Proficient 100 tablets — AB FDA listed —
Meloxicam 15 mg 71335-1888-00 Bryant 20 tablets — AB FDA listed —
meloxicam 15 mg 71335-1956-00 Bryant 20 tablets — AB FDA listed —
Meloxicam 15 mg 71335-2327-00 Bryant 20 tablets — AB FDA listed —
Meloxicam 15 mg 71610-0542-30 Aphena 30 tablets — AB FDA listed —
Meloxicam 15 mg 71610-0544-30 Aphena 30 tablets — AB FDA listed —
meloxicam 15 mg 71610-0580-30 Aphena 30 tablets — AB FDA listed —
Meloxicam 15 mg 71610-0657-30 Aphena 30 tablets — AB FDA listed —
Meloxicam 15 mg 71610-0872-30 Aphena 30 tablets — AB FDA listed —
Meloxicam 15 mg 72162-1738-00 Bryant 1000 tablets — AB FDA listed —
Meloxicam 15 mg 72789-0403-07 PD-Rx 7 tablets — AB FDA listed —
Meloxicam 15 mg 72789-0447-14 PD-Rx 14 tablets — AB FDA listed —
Meloxicam 15 mg 72865-0138-01 XLCare 100 tablets — AB FDA listed —
Meloxicam 15 mg 72865-0333-01 XLCare 100 tablets — AB FDA listed —
meloxicam 15 mg 76420-0039-10 Asclemed 10 tablets — AB FDA listed —
Meloxicam 15 mg 76420-0326-00 Asclemed 1000 tablets — AB FDA listed —
Meloxicam 15 mg 80425-0044-01 Advanced 30 tablets — AB FDA listed —
Meloxicam 15 mg 80425-0045-01 Advanced 30 tablets — AB FDA listed —
Meloxicam 15 mg 80425-0083-01 Advanced 30 tablets — AB FDA listed —
Meloxicam 15 mg 80425-0584-01 Advanced 30 tablets — AB FDA listed —
Meloxicam 15 mg 80425-0585-01 Advanced 30 tablets — AB FDA listed —
Meloxicam 15 mg 80425-0586-01 Advanced 30 tablets — AB FDA listed —
Meloxicam 15 mg 82461-0712-30 Medcore 30 tablets — AB FDA listed —
Meloxicam 15 mg 82804-0029-07 Proficient 7 tablets — AB FDA listed —
meloxicam 15 mg 85509-1051-03 PHOENIX 30 tablets — AB FDA listed —
meloxicam 15 mg 85509-1125-03 PHOENIX 30 tablets — AB FDA listed —
Meloxicam 15 mg 85509-1159-03 PHOENIX 30 tablets — AB FDA listed —
meloxicam 15 mg 85766-0036-01 Sportpharm 100 tablets — AB FDA listed —
Meloxicam 15 mg 68180-0502-01 Lupin 100 tablets — — Discontinued —
meloxicam 15 mg 85534-0020-00 HAWAII 30 tablets — AB FDA listed —
Meloxicam 15 mg 72189-0684-30 Direct_Rx 30 tablets — AB FDA listed —
meloxicam 15 mg 67296-1460-03 Redpharm 30 tablets — AB Discontinued —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2010
On the market since
Jun 2010
📍
2026
Currently FDA-listed
16 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAphena Pharma Solutions - Tennessee, LLC
Application holderYUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
FDA applicationANDA077918 (ANDA)
Labeler code43353
First marketedJun 2010
Product typeHuman Prescription Drug
Portfolio800 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS Cardiovascular Risk Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see Warnings and Precautions ( 5.1 )].

Meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications ( 4.2 ) and Warnings and Precautions ( 5.1 ) ]. Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse reactions including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms.

Elderly patients are at greater risk for serious gastrointestinal events [ see Warnings and Precautions ( 5.2 ) ]. WARNING: CARDIOVASCULAR and GASTROINTESTINAL RISKS See full prescribing information for complete boxed warning . Cardiovascular Risk NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.

This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. ( 5.1 ) Meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery ( 4.2 , 5.1 ) Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. ( 5.2 )

🎯 Indications and Usage 135 words ▾

1 INDICATIONS AND USAGE Meloxicam is a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) ( 1.1 ) Rheumatoid Arthritis (RA) ( 1.2 ) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older ( 1.3 )

1.1Osteoarthritis (OA) Meloxicam tablets, USP is indicated for relief of the signs and symptoms of osteoarthritis [ see Clinical Studies ( 14.1 ) ].

1.2Rheumatoid Arthritis (RA) Meloxicam tablets, USP is indicated for relief of the signs and symptoms of rheumatoid arthritis [ see Clinical Studies ( 14.1 ) ].

1.3Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course Meloxicam tablets, USP is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [ see Clinical Studies ( 14.2 ) ].

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Use the lowest effective dose for the shortest duration consistent with individual treatment goals for the individual patient. OA ( 2.2 ) and RA ( 2.3 ): Starting dose: 7.5 mg once daily Dose may be increased to 15 mg once daily

2.1General Instructions Carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions ( 5.4 ) ]. After observing the response to initial therapy with meloxicam, adjust the dose to suit an individual patient's needs.

In adults, the maximum recommended daily oral dose of meloxicam is 15 mg regardless of formulation. In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended [ see Warnings and Precautions ( 5.6 ), Use in Specific Populations ( 8.7 ), and Clinical Pharmacology ( 12.3 ) ]. Meloxicam may be taken without regard to timing of meals.

2.2Osteoarthritis For the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of meloxicam is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.

2.3Rheumatoid Arthritis For the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of meloxicam is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.

💊 Dosage Forms and Strengths 62 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 7.5 mg: pastel yellow, round, biconvex, uncoated tablet containing meloxicam 7.5 mg. The 7.5 mg tablet is impressed with “5” mark on one side. 15 mg: pastel yellow, round, biconvex, uncoated tablet containing meloxicam 15 mg. The 15 mg tablet is impressed with “100” mark on one side. Tablets: 7.5 mg, 15 mg ( 3 )

⛔ Contraindications 147 words ▾

4 CONTRAINDICATIONS Known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to meloxicam ( 4.1 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4.1 ) Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery ( 4.2 )

4.1Allergic Reactions Meloxicam is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to meloxicam. Meloxicam should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients [ see Warnings and Precautions ( 5.7 , 5.13 ) ].

4.2Coronary Surgery Meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions ( 5.1 ) ].

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke. Patients with known CV disease/risk factors may be at greater risk. ( 5.1 ) Serious gastrointestinal (GI) adverse events which can be fatal.

The risk is greater in patients with a prior history of ulcer disease or GI bleeding, and in patients at higher risk for GI events, especially the elderly. ( 5.2 ) Elevated liver enzymes, and rarely, severe hepatic reactions. Discontinue use immediately if abnormal liver enzymes persist or worsen.

( 5.3 ) New onset or worsening of hypertension. Blood pressure should be monitored closely during treatment. ( 5.4 ) Fluid retention and edema.

Should be used with caution in patients with fluid retention or heart failure. ( 5.5 ) Renal papillary necrosis and other renal injury with long-term use. Use with caution in the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics, ACE-inhibitors, or angiotensin II antagonists.

The use of meloxicam in patients with severe renal impairment is not recommended. ( 5.6 ) Serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal and can occur without warning. Discontinue meloxicam at first appearance of rash or skin reactions.

( 5.8 )

5.1Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years' duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk.

To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.

Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke [ see Contraindications ( 4.2 ) ]. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events [ see Warnings and Precautions ( 5.2 ) ].

5.2Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and Perforation NSAIDs, including meloxicam, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic.

Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs, occur in approximately 1% of patients treated for 3 to 6 months, and in about 2 to 4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.

Prescribe NSAIDs, including meloxicam, with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to pa… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular thrombotic events [ see Boxed Warning and Warnings and Precautions ( 5.1 )] Gastrointestinal effects – risk of GI ulceration, bleeding, and perforation [ see Boxed Warning and Warnings and Precautions ( 5.2 ) ] Hepatic effects [see Warnings and Precautions ( 5.3 )] Hypertension [see Warnings and Precautions ( 5.4 )] Congestive heart failure and edema [see Warnings and Precautions ( 5.5 )] Renal effects [see Warnings and Precautions ( 5.6 )] Anaphylactoid reactions [ see Warnings and Precautions ( 5.7 )] Adverse skin reactions [see Warnings and Precautions ( 5.8 )] Most common (≥5% and greater than placebo) adverse events in adults are diarrhea, upper respiratory tract infections, dyspepsia, and influenza-like symptoms ( 6.1 ) Adverse events observed in pediatric studies were similar in nature to the adult clinical trial experience ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Carlsbad Technology, Inc. at 1-866-431-8284 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch .

6.1Clinical Trials Experience Adults Osteoarthritis and Rheumatoid Arthritis The meloxicam Phase 2/3 clinical trial database includes 10,122 OA patients and 1012 RA patients treated with meloxicam 7.5 mg/day, 3505 OA patients and 1351 RA patients treated with meloxicam 15 mg/day. Meloxicam at these doses was administered to 661 patients for at least 6 months and to 312 patients for at least one year. Approximately 10,500 of these patients were treated in ten placebo- and/or active-controlled osteoarthritis trials and 2363 of these patients were treated in ten placebo- and/or active-controlled rheumatoid arthritis trials.

Gastrointestinal (GI) adverse events were the most frequently reported adverse events in all treatment groups across meloxicam trials. A 12-week multicenter, double-blind, randomized trial was conducted in patients with osteoarthritis of the knee or hip to compare the efficacy and safety of meloxicam with placebo and with an active control. Two 12-week multicenter, double-blind, randomized trials were conducted in patients with rheumatoid arthritis to compare the efficacy and safety of meloxicam with placebo.

Table 1a depicts adverse events that occurred in ≥2% of the meloxicam treatment groups in a 12-week placebo- and active-controlled osteoarthritis trial. Table 1b depicts adverse events that occurred in ≥2% of the meloxicam treatment groups in two 12-week placebo- controlled rheumatoid arthritis trials. Table 1a Adverse Events (%) Occurring in ≥2% of Meloxicam Patients in a 12-Week Osteoarthritis Placebo- and Active-Controlled Trial Placebo Meloxicam 7.5 mg daily Meloxicam 15 mg daily Diclofenac 100 mg daily No. of Patients 157 154 156 153 Gastrointestinal 17.2 20.1 17.3

28.1Abdominal Pain 2.5 1.9 2.6

1.3Diarrhea 3.8 7.8 3.2

9.2Dyspepsia 4.5 4.5 4.5

6.5Flatulence 4.5 3.2 3.2

3.9Nausea 3.2 3.9 3.8

7.2Body as a Whole Accident Household 1.9 4.5 3.2

2.6Edema 1 2.5 1.9 4.5

3.3Fall 0.6 2.6 0.0

1.3Influenza-Like Symptoms 5.1 4.5 5.8

2.6Central and Peripheral Nervous System Dizziness 3.2 2.6 3.8

2.0Headache 10.2 7.8 8.3

5.9Respiratory Pharyngitis 1.3 0.6 3.2

1.3Upper Respiratory Tract Infection 1.9 3.2 1.9

3.3Skin Rash 2 2.5 2.6 0.6 2.0 1 WHO preferred terms edema, edema dependent, edema peripheral and edema legs combined 2 WHO preferred terms rash, rash erythematous and rash maculo-papular combined Table 1b Adverse Events (%) Occurring in ≥2% of Meloxicam Patients in two 12-Week Rheumatoid Arthritis Placebo-Controlled Trials Placebo Meloxicam 7.5 mg daily Meloxicam 15 mg No. of Patients 469 481 477 Gastrointestinal Disorders 14.1 18.9

16.8Abdom… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS See also Clinical Pharmacology ( 12.3 ). Concomitant use of meloxicam and warfarin may result in increased risk of bleeding complications ( 7.7 ) Concomitant use of meloxicam and aspirin is not generally recommended because of the potential of increased adverse effect including increased GI bleeding ( 7.2 ) Concomitant use with meloxicam increases lithium plasma levels ( 7.4 ) Concomitant use with NSAIDs may reduce the antihypertensive effect of ACE-inhibitors ( 7.1 )

7.1ACE-inhibitors NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking meloxicam concomitantly with ACE-inhibitors.

7.2Aspirin When meloxicam is administered with aspirin (1000 mg three times daily) to healthy volunteers, an increase the AUC (10%) and C max (24%) of meloxicam was noted. The clinical significance of this interaction is not known; however, as with other NSAIDs concomitant administration of meloxicam and aspirin is not generally recommended because of the potential for increased adverse effects. Concomitant administration of low-dose aspirin with meloxicam may result in an increased rate of GI ulceration or other complications, compared to use of meloxicam alone.

Meloxicam is not a substitute for aspirin for cardiovascular prophylaxis.

7.3Diuretics Clinical studies, as well as post marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. However, studies with furosemide agents and meloxicam have not demonstrated a reduction in natriuretic effect.

Furosemide single and multiple dose pharmacodynamics and pharmacokinetics are not affected by multiple doses of meloxicam. Nevertheless, during concomitant therapy with meloxicam, patients should be observed closely for signs of renal failure [ see Warnings and Precautions ( 5.6 ) ], as well as to ensure diuretic efficacy.

7.4Lithium In a study conducted in healthy subjects, mean pre-dose lithium concentration and AUC were increased by 21% in subjects receiving lithium doses ranging from 804 to 1072 mg twice daily with meloxicam 15 mg every day as compared to subjects receiving lithium alone. These effects have been attributed to inhibition of renal prostaglandin synthesis by meloxicam. Closely monitor patients on lithium treatment for signs of lithium toxicity when meloxicam is introduced, adjusted, or withdrawn.

7.5Methotrexate NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. Therefore, NSAIDs may reduce the elimination of methotrexate, thereby enhancing the toxicity of methotrexate. Use caution when meloxicam is administered concomitantly with methotrexate [ see Clinical Pharmacology ( 12.3 ) ].

7.6Cyclosporine Meloxicam, like other NSAIDs, may affect renal prostaglandins, thereby altering the renal toxicity of certain drugs. Therefore, concomitant therapy with meloxicam may increase cyclosporine's nephrotoxicity. Use caution when meloxicam is administered concomitantly with cyclosporine.

7.7Warfarin The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. Monitor anticoagulant activity, particularly in the first few days after initiating or changing meloxicam therapy in patients receiving warfarin or similar agents, since these patients are at an increased risk of bleeding than with the use of either drug alone. Use caution when administering meloxicam with warfarin since patients on warfarin may experience changes in INR and an increased risk of bleeding complications when a new medication is introduced [ see Clinical Pharmacology ( 12.3 ) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Based on animal data, may cause fetal harm. Starting at 30 weeks gestation, meloxicam should be avoided as premature closure of the ductus arteriosus in the fetus may occur. ( 5.9 , 8.1 ) Nursing Mothers: Use with caution, as meloxicam may be excreted in human milk ( 8.3 )

8.1Pregnancy Pregnancy Category C; Category D starting 30 weeks gestation There are no adequate and well-controlled studies in pregnant women. Meloxicam crosses the placental barrier. Prior to 30 weeks gestation, use meloxicam during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Starting at 30 weeks gestation, avoid meloxicam and other NSAIDs, in pregnant women as premature closure of the ductus arteriosus in the fetus may occur. If this drug is used during this time period in pregnancy, inform the patient of the potential hazard to a fetus [ see Warnings and Precautions ( 5.9 ) and Patient Counseling Information ( 17.8 ) ]. Teratogenic Effects Meloxicam was not teratogenic when administered to pregnant rats during fetal organogenesis at oral doses up to 4 mg/kg/day (2.6-fold greater than the maximum recommended human daily dose [MRHD] based on body surface area [BSA] comparison).

Administration of meloxicam to pregnant rabbits throughout embryogenesis produced an increased incidence of septal defects of the heart at an oral dose of 60 mg/kg/day. The no effect level was 20 mg/kg/day (26-fold greater than the MRHD based on BSA conversion). Nonteratogenic Effects In rats and rabbits, embryolethality occurred at oral meloxicam doses of 1 mg/kg/day and 5 mg/kg/day, respectively (0.65-and 6.5-fold greater, respectively, than the MRHD based on BSA comparison) when administered throughout organogenesis.

8.2Labor and Delivery The effects of meloxicam on labor and delivery of pregnant women are unknown. Oral administration of meloxicam to pregnant rats during late gestation through lactation increased the incidence of dystocia, delayed parturition, and decreased offspring survival at meloxicam doses of 0.125 mg/kg/day or greater (at least 12.5 times lower than the maximum recommended human daily dose based on body surface area comparison).

8.3Nursing Mothers It is not known whether this drug is excreted in human milk; however, meloxicam was excreted in the milk of lactating rats at concentrations higher than those in plasma. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from meloxicam, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4Pediatric Use The safety and effectiveness of meloxicam in pediatric JRA patients from 2 to 17 years of age has been evaluated in three clinical trials [ see Dosage and Administration ( 2.3 ), Adverse Reactions ( 6.1 ), and Clinical Studies ( 14.2 ) ]

8.5Geriatric Use As with any NSAID, caution should be exercised in treating the elderly (65 years and older). Of the total number of subjects in clinical studies, 5157 were age 65 and over (4044 in OA studies and 1113 in RA studies). No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

8.6Hepatic Impairment No dose adjustment is necessary in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment have not been adequately studied. Since meloxicam is significantly metabolized in the liver; the use of meloxicam in these patients should be done with caution [ see Warnings and Precautions ( 5.3 ) and Clinical Pharmacology ( 12.3 ) ].

8.7Renal Impairment No dose adjustment is necessary in patients with mild to moderate renal impairment. Patients with severe renal imp… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Pregnancy Category C; Category D starting 30 weeks gestation There are no adequate and well-controlled studies in pregnant women. Meloxicam crosses the placental barrier. Prior to 30 weeks gestation, use meloxicam during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Starting at 30 weeks gestation, avoid meloxicam and other NSAIDs, in pregnant women as premature closure of the ductus arteriosus in the fetus may occur. If this drug is used during this time period in pregnancy, inform the patient of the potential hazard to a fetus [ see Warnings and Precautions ( 5.9 ) and Patient Counseling Information ( 17.8 ) ]. Teratogenic Effects Meloxicam was not teratogenic when administered to pregnant rats during fetal organogenesis at oral doses up to 4 mg/kg/day (2.6-fold greater than the maximum recommended human daily dose [MRHD] based on body surface area [BSA] comparison).

Administration of meloxicam to pregnant rabbits throughout embryogenesis produced an increased incidence of septal defects of the heart at an oral dose of 60 mg/kg/day. The no effect level was 20 mg/kg/day (26-fold greater than the MRHD based on BSA conversion). Nonteratogenic Effects In rats and rabbits, embryolethality occurred at oral meloxicam doses of 1 mg/kg/day and 5 mg/kg/day, respectively (0.65-and 6.5-fold greater, respectively, than the MRHD based on BSA comparison) when administered throughout organogenesis.

🧒 Pediatric Use 47 words ▾

8.4Pediatric Use The safety and effectiveness of meloxicam in pediatric JRA patients from 2 to 17 years of age has been evaluated in three clinical trials [ see Dosage and Administration ( 2.3 ), Adverse Reactions ( 6.1 ), and Clinical Studies ( 14.2 ) ]

🧓 Geriatric Use 86 words ▾

8.5Geriatric Use As with any NSAID, caution should be exercised in treating the elderly (65 years and older). Of the total number of subjects in clinical studies, 5157 were age 65 and over (4044 in OA studies and 1113 in RA studies). No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 194 words ▾

10 OVERDOSAGE There is limited experience with meloxicam overdose. Four cases have taken 6 to 11 times the highest recommended dose; all recovered. Cholestyramine is known to accelerate the clearance of meloxicam.

Symptoms following acute NSAID overdose include lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Severe poisoning may result in hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular collapse, and cardiac arrest.

Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Patients should be managed with symptomatic and supportive care following an NSAID overdose. Administration of activated charcoal is recommended for patients who present 1 to 2 hours after overdose.

For substantial overdose or severely symptomatic patients, activated charcoal may be administered repeatedly. Accelerated removal of meloxicam by 4 g oral doses of cholestyramine given three times a day was demonstrated in a clinical trial. Administration of cholestyramine may be useful following an overdose.

Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdose treatment, call a poison control center (1-800-222-1222).

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of meloxicam, like that of other NSAIDs, may be related to prostaglandin synthetase (cyclo-oxygenase) inhibition which is involved in the intial steps of the arachidonic acid cascade, resulting in the reduced formation of prostaglandins, thromboxanes and prostacylin. It is not completely understood how reduced synthesis of these compounds results in therapeutic efficacy.

12.2Pharmacodynamics Meloxicam exhibits anti-inflammatory, analgesic, and antipyretic activities.

12.3Pharmacokinetics Absorption The absolute bioavailability of meloxicam capsules was 89% following a single oral dose of 30 mg compared with 30 mg IV bolus injection. Following single intravenous doses, dose-proportional pharmacokinetics were shown in the range of 5 mg to 60 mg. After multiple oral doses the pharmacokinetics of meloxicam capsules were dose-proportional over the range of 7.5 mg to 15 mg.

Mean C max was achieved within four to five hours after a 7.5 mg meloxicam tablet was taken under fasted conditions, indicating a prolonged drug absorption. With multiple dosing, steady-state concentrations were reached by Day 5. A second meloxicam concentration peak occurs around 12 to 14 hours post-dose suggesting biliary recycling.

Meloxicam capsules have been shown to be bioequivalent to meloxicam tablets. Table 3 Single Dose and Steady-State Pharmacokinetic Parameters for Oral 7.5 mg and 15 mg Meloxicam (Mean and % CV) 1 Steady State Single Dose Pharmacokinetic Parameters (%CV) Healthy male adults (Fed) 2 Elderly males (Fed) 2 Elderly Females (Fed) 2 Renal Failure (Fasted) Hepatic insufficiency (Fasted) 7.5 mg 3 tablets 15 mg capsules 15 mg capsules 15 mg capsules 15 mg capsules N 18 5 8 12 12 C max [mcg/mL] 1.05 (20) 2.3 (59) 3.2 (24) 0.59 (36) 0.84 (29) t max [h] 4.9 (8) 5 (12) 6 (27) 4 (65) 10 (87) t 1/2 [h] 20.1 (29) 21 (34) 24 (34) 18 (46) 16 (29) CL/f [mL/min] 8.8 (29) 9.9 (76) 5.1 (22) 19 (43) 11 (44) V z /f 4 [L] 14.7 (32) 15 (42) 10 (30) 26 (44) 14 (29) 1 The parameter values in the Table are from various studies 2 not under high fat conditions 3 Meloxicam tablets 4 V z /f =Dose/(AUCK el ) Food and Antacid Effects Administration of meloxicam capsules following a high fat breakfast (75 g of fat) resulted in mean peak drug levels (i.e., C max ) being increased by approximately 22% while the extent of absorption (AUC) was unchanged.

The time to maximum concentration (T max ) was achieved between 5 and 6 hours. In comparison, neither the AUC nor the C max values for meloxicam suspension were affected following a similar high fat meal, while mean T max values were increased to approximately 7 hours. No pharmacokinetic interaction was detected with concomitant administration of antacids.

Based on these results, meloxicam can be administered without regard to timing of meals or concomitant administration of antacids. Distribution The mean volume of distribution (Vss) of meloxicam is approximately 10 L. Meloxicam is ~99.4% bound to human plasma proteins (primarily albumin) within the therapeutic dose range.

The fraction of protein binding is independent of drug concentration, over the clinically relevant concentration range, but decreases to ~99% in patients with renal disease. Meloxicam penetration into human red blood cells, after oral dosing, is less than 10%. Following a radiolabeled dose, over 90% of the radioactivity detected in the plasma was present as unchanged meloxicam.

Meloxicam concentrations in synovial fluid, after a single oral dose, range from 40% to 50% of those in plasma. The free fraction in synovial fluid is 2.5 times higher than in plasma, due to the lower albumin content in synovial fluid as compared to plasma. The significance of this penetration is unknown.

Metabolism Meloxicam is extensively metabolized in the liver. Meloxicam metabolites include 5'-carboxy meloxicam (60% of dose), from P-450 mediated metabolism formed by oxidation of an intermediate metabo… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 60 words ▾

12.1Mechanism of Action The mechanism of action of meloxicam, like that of other NSAIDs, may be related to prostaglandin synthetase (cyclo-oxygenase) inhibition which is involved in the intial steps of the arachidonic acid cascade, resulting in the reduced formation of prostaglandins, thromboxanes and prostacylin. It is not completely understood how reduced synthesis of these compounds results in therapeutic efficacy.

📦 How Supplied / Storage and Handling 134 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Meloxicam is available as a pastel yellow, round, biconvex, uncoated tablet containing meloxicam 7.5 mg or 15 mg. The 7.5 mg tablet is impressed with “5” mark on one side, and the 15 mg tablet is impressed with “100” mark on one side. Meloxicam Tablets, USP 7.5 mg is available as follows: NDC 61442-126-30; Bottles of 30 NDC 61442-126-01; Bottles of 100 NDC 61442-126-10; Bottles of 1000 Meloxicam Tablets, USP 15 mg is available as follows: NDC 61442-127-30; Bottles of 30 NDC 61442-127-01; Bottles of 100 NDC 61442-127-10; Bottles of 1000 Storage Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].

Keep Meloxicam Tablets, USP in a dry place. Dispense tablets in a tight container. Keep this and all medications out of the reach of children.

📦 Storage and Handling 38 words ▾

Storage Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Keep Meloxicam Tablets, USP in a dry place. Dispense tablets in a tight container. Keep this and all medications out of the reach of children.

📋 Description 163 words ▾

11 DESCRIPTION Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each pastel yellow Meloxicam Tablets, USP contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N -(5-methyl-2-thiazolyl)-2 H -1,2-benzothiazine-3-carboxamide-1,1-dioxide.

The molecular weight is 351.4. Its empirical formula is C 14 H 13 N 3 O 4 S 2 and it has the following structural formula: Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol.

Meloxicam has an apparent partition coefficient (log P) app = 0.1 in n -octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam.

The inactive ingredients in Meloxicam Tablets, USP include Colloidal Silicon Dioxide, Sodium Starch Glycolate, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Povidone K-30, and Sodium Citrate. Structural Formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved Medication Guide Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy.

17.1Medication Guide Inform patients of the availability of a Medication Guide for NSAIDs that accompanies each prescription dispensed, and instruct them to read the Medication Guide prior to using meloxicam.

17.2Cardiovascular Effects NSAIDs including meloxicam may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up [ see Warnings and Precautions ( 5.1 ) ].

17.3Gastrointestinal Effects NSAIDs including meloxicam, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up [ see Warnings and Precautions ( 5.2 ) ].

17.4Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, instruct patients to stop therapy and seek immediate medical therapy [ see Warnings and Precautions ( 5.3 ) ].

17.5Adverse Skin Reactions NSAIDs, including meloxicam, can cause serious skin side effects such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which may result in hospitalization and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms.

Advise patients to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible [ see Warnings and Precautions ( 5.8 ) ].

17.6Weight Gain and Edema Advise patients to promptly report signs or symptoms of unexplained weight gain or edema to their physicians [ see Warnings and Precautions ( 5.5 ) ].

17.7Anaphylactoid Reactions Inform patients of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients seek immediate emergency help [ see Warnings and Precautions ( 5.7 ) ].

17.8Effects During Pregnancy Starting at 30 weeks gestation, meloxicam should be avoided as premature closure of the ductus arteriosus in the fetus may occur [see Warnings and Precautions ( 5.9 ) and Use in Specific Populations ( 8.1 )].

17.9Effects On Female Fertility Advise females of reproductive potential who desire pregnancy that NSAIDs, including Meloxicam, may be associated with a reversible delay in ovulation For women who have difficulties conceiving, or who are undergoing investigation of infertility, use of meloxicam is not recommended [ see Use in Specific Populations 8.8 ) ]. Please address medical inquiries to 1-760-431-8284 Manufactured by: Yung Shin Pharmaceutical Ind. Co., Ltd.

Tachia, Taichung 43769 TAIWAN Distributed by: Carlsbad Technology, Inc. 5923 Balfour Ct. Carlsbad, CA 92008 USA Revised: 08/13

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE MELOXICAM Tablets, USP Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: with longer use of NSAID medicines in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG)." NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment.

Ulcers and bleeding: can happen without warning symptoms may cause death The chance of a person getting an ulcer or bleeding increases with: taking medicines called "corticosteroids" and "anticoagulants" longer use smoking drinking alcohol older age having poor health NSAID medicines should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What are Non-Steroidal Anti- Inflammatory Drugs (NSAIDs)? NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: different types of arthritis menstrual cramps and other types of short-term pain Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine: if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine for pain right before or after heart bypass surgery Tell your healthcare provider: about all of your medical conditions. about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause seri- ous side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. if you are pregnant.

NSAID medicines should not be used by pregnant women late in their pregnancy. if you are breastfeeding. Talk to your doctor. What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Serious side effects include: heart attack stroke high blood pressure heart failure from body swelling (fluid retention) kidney problems including kidney failure bleeding and ulcers in the stomach and intestine low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions liver problems including liver failure asthma attacks in people who have asthma Other side effects include: stomach pain constipation diarrhea gas heartburn nausea vomiting dizziness Get emergency help right away if you have any of the following symptoms: shortness of breath or trouble breathing chest pain weakness in one part or side of your body slurred speech swelling of the face or throat Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: nausea more tired or weaker than usual itching your skin or eyes look yellow stomach pain flu-like symptoms vomit blood there is blood in your bowel movement or it is black and sticky like tar unusual weight gain skin rash or blisters with fever swelling of the arms and legs, hands and feet These are not all the side effects with NSAID medicines.

Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.

Some of these NSAID medicines are sold in lower doses without a prescription (over-the¬counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days. NS… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 79 words ▾

8.3Nursing Mothers It is not known whether this drug is excreted in human milk; however, meloxicam was excreted in the milk of lactating rats at concentrations higher than those in plasma. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from meloxicam, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption The absolute bioavailability of meloxicam capsules was 89% following a single oral dose of 30 mg compared with 30 mg IV bolus injection. Following single intravenous doses, dose-proportional pharmacokinetics were shown in the range of 5 mg to 60 mg. After multiple oral doses the pharmacokinetics of meloxicam capsules were dose-proportional over the range of 7.5 mg to 15 mg.

Mean C max was achieved within four to five hours after a 7.5 mg meloxicam tablet was taken under fasted conditions, indicating a prolonged drug absorption. With multiple dosing, steady-state concentrations were reached by Day 5. A second meloxicam concentration peak occurs around 12 to 14 hours post-dose suggesting biliary recycling.

Meloxicam capsules have been shown to be bioequivalent to meloxicam tablets. Table 3 Single Dose and Steady-State Pharmacokinetic Parameters for Oral 7.5 mg and 15 mg Meloxicam (Mean and % CV) 1 Steady State Single Dose Pharmacokinetic Parameters (%CV) Healthy male adults (Fed) 2 Elderly males (Fed) 2 Elderly Females (Fed) 2 Renal Failure (Fasted) Hepatic insufficiency (Fasted) 7.5 mg 3 tablets 15 mg capsules 15 mg capsules 15 mg capsules 15 mg capsules N 18 5 8 12 12 C max [mcg/mL] 1.05 (20) 2.3 (59) 3.2 (24) 0.59 (36) 0.84 (29) t max [h] 4.9 (8) 5 (12) 6 (27) 4 (65) 10 (87) t 1/2 [h] 20.1 (29) 21 (34) 24 (34) 18 (46) 16 (29) CL/f [mL/min] 8.8 (29) 9.9 (76) 5.1 (22) 19 (43) 11 (44) V z /f 4 [L] 14.7 (32) 15 (42) 10 (30) 26 (44) 14 (29) 1 The parameter values in the Table are from various studies 2 not under high fat conditions 3 Meloxicam tablets 4 V z /f =Dose/(AUCK el ) Food and Antacid Effects Administration of meloxicam capsules following a high fat breakfast (75 g of fat) resulted in mean peak drug levels (i.e., C max ) being increased by approximately 22% while the extent of absorption (AUC) was unchanged.

The time to maximum concentration (T max ) was achieved between 5 and 6 hours. In comparison, neither the AUC nor the C max values for meloxicam suspension were affected following a similar high fat meal, while mean T max values were increased to approximately 7 hours. No pharmacokinetic interaction was detected with concomitant administration of antacids.

Based on these results, meloxicam can be administered without regard to timing of meals or concomitant administration of antacids. Distribution The mean volume of distribution (Vss) of meloxicam is approximately 10 L. Meloxicam is ~99.4% bound to human plasma proteins (primarily albumin) within the therapeutic dose range.

The fraction of protein binding is independent of drug concentration, over the clinically relevant concentration range, but decreases to ~99% in patients with renal disease. Meloxicam penetration into human red blood cells, after oral dosing, is less than 10%. Following a radiolabeled dose, over 90% of the radioactivity detected in the plasma was present as unchanged meloxicam.

Meloxicam concentrations in synovial fluid, after a single oral dose, range from 40% to 50% of those in plasma. The free fraction in synovial fluid is 2.5 times higher than in plasma, due to the lower albumin content in synovial fluid as compared to plasma. The significance of this penetration is unknown.

Metabolism Meloxicam is extensively metabolized in the liver. Meloxicam metabolites include 5'-carboxy meloxicam (60% of dose), from P-450 mediated metabolism formed by oxidation of an intermediate metabolite 5'-hydroxymethyl meloxicam which is also excreted to a lesser extent (9% of dose). In vitro studies indicate that CYP2C9 (cytochrome P450 metabolizing enzyme) plays an important role in this metabolic pathway with a minor contribution of the CYP3A4 isozyme.

Patients' peroxidase activity is probably responsible for the other two metabolites which account for 16% and 4% of the administered dose, respectively. All the four metabolites are not known to have any in vivo pharmacological activity. Excretion Meloxicam excretion is predominantly… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 9 words ▾

12.2Pharmacodynamics Meloxicam exhibits anti-inflammatory, analgesic, and antipyretic activities.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES

14.1Osteoarthritis and Rheumatoid Arthritis The use of meloxicam for the treatment of the signs and symptoms of osteoarthritis of the knee and hip was evaluated in a 12-week, double-blind, controlled trial. Meloxicam (3.75 mg, 7.5 mg, and 15 mg daily) was compared to placebo. The four primary endpoints were investigator's global assessment, patient global assessment, patient pain assessment, and total WOMAC score (a self-administered questionnaire addressing pain, function, and stiffness).

Patients on meloxicam 7.5 mg daily and meloxicam 15 mg daily showed significant improvement in each of these endpoints compared with placebo. The use of meloxicam for the management of signs and symptoms of osteoarthritis was evaluated in six double-blind, active-controlled trials outside the U.S. ranging from 4 weeks' to 6 months' duration. In these trials, the efficacy of meloxicam, in doses of 7.5 mg/day and 15 mg/day, was comparable to piroxicam 20 mg/day and diclofenac SR 100 mg/day and consistent with the efficacy seen in the U.S. trial.

The use of meloxicam for the treatment of the signs and symptoms of rheumatoid arthritis was evaluated in a 12-week, double-blind, controlled multinational trial. Meloxicam (7.5 mg, 15 mg, and 22.5 mg daily) was compared to placebo. The primary endpoint in this study was the ACR20 response rate, a composite measure of clinical, laboratory, and functional measures of RA response.

Patients receiving meloxicam 7.5 mg and 15 mg daily showed significant improvement in the primary endpoint compared with placebo. No incremental benefit was observed with the 22.5 mg dose compared to the 15 mg dose.

14.2Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course The use of meloxicam for the treatment of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older was evaluated in two 12-week, double-blind, parallel-arm, active-controlled trials. Both studies included three arms: naproxen and two doses of meloxicam. In both studies, meloxicam dosing began at 0.125 mg/kg/day (7.5 mg maximum) or 0.25 mg/kg/day (15 mg maximum), and naproxen dosing began at 10 mg/kg/day.

One study used these doses throughout the 12-week dosing period, while the other incorporated a titration after 4 weeks to doses of 0.25 mg/kg/day and 0.375 mg/kg/day (22.5 mg maximum) of meloxicam and 15 mg/kg/day of naproxen. The efficacy analysis used the ACR Pediatric 30 responder definition, a composite of parent and investigator assessments, counts of active joints and joints with limited range of motion, and erythrocyte sedimentation rate. The proportion of responders were similar in all three groups in both studies, and no difference was observed between the meloxicam dose groups.

🧪 Nonclinical Toxicology 141 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: There was no increase in tumor incidence in long-term carcinogenicity studies in rats (104 weeks) and mice (99 weeks) administered meloxicam at oral doses up to 0.8 mg/kg/day in rats and up to 8.0 mg/kg/day in mice (up to 0.5- and 2.6-fold, respectively, the maximum recommended human daily dose based on body surface area comparison). Mutagenesis: Meloxicam was not mutagenic in an Ames assay, or clastogenic in a chromosome aberration assay with human lymphocytes and an in vivo micronucleus test in mouse bone marrow.

Impairment of Fertility: Meloxicam did not impair male and female fertility in rats at oral doses up to 9 mg/kg/day in males and 5 mg/kg/day in females (up to 5.8- and 3.2-fold greater, respectively, than the maximum recommended human daily dose based on body surface area comparison).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 138 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: There was no increase in tumor incidence in long-term carcinogenicity studies in rats (104 weeks) and mice (99 weeks) administered meloxicam at oral doses up to 0.8 mg/kg/day in rats and up to 8.0 mg/kg/day in mice (up to 0.5- and 2.6-fold, respectively, the maximum recommended human daily dose based on body surface area comparison). Mutagenesis: Meloxicam was not mutagenic in an Ames assay, or clastogenic in a chromosome aberration assay with human lymphocytes and an in vivo micronucleus test in mouse bone marrow.

Impairment of Fertility: Meloxicam did not impair male and female fertility in rats at oral doses up to 9 mg/kg/day in males and 5 mg/kg/day in females (up to 5.8- and 3.2-fold greater, respectively, than the maximum recommended human daily dose based on body surface area comparison).

📄 Package Label / Principal Display Panel 14 words ▾

PRINCIPAL DISPLAY PANEL NDC 43353-979 - Meloxicam 15mg - Rx Only Bottle Label 15mg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Meloxicam — the program that covers self-administered drugs. 12 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Meloxicam. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$15.31M
Claims incl. refills
3M
Beneficiaries
2.1M
Spend / beneficiary
$7.39
Spend / claim
$5.08
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aphena Pharma Solutions - Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 tablets (43353-0979-30). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Aphena Pharma Solutions - Tennessee, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 43353-0978-92 · Aphena 43353-0982-30 · Aphena →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.