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Meloxicam 7.5 mg Tablet, 60-count — NDC 80425-0042-2 (Billing 80425-0042-02)

by Advanced Rx of Tennessee, LLC · 60 TABLET in 1 BOTTLE

This is a package of 60 tablets of Meloxicam 7.5 mg Tablet from Advanced Rx of Tennessee, LLC, marketed since Jul 2006 and currently FDA-listed.

NDC 80425-0042-02
🏷️ FDA NDC (as labeled) 80425-0042-2 billing pads the package segment with a zero
This package
Contains60-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.0985/unit — full pricing hub ↓
Product page 80425-0042-01 Also comes in: 30 tablets 80425-0042-1 90 tablets 80425-0042-3
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) 80425-0042-2
Product NDC 80425-0042
11-digit billing NDC 80425004202
NCPDP billing unit EA — each (per item)
RxCUI 311486
UNII VG2QF83CGL
Application # ANDA077921
SPL Set ID af9cf496-d505-f2ba-e053-2995a90a76cf
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 2006-07-19
Route ORAL
Dosage form TABLET
Substance MELOXICAM
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 311486
Why two NDCs? The FDA registers this code as 80425-0042-2 — a 5-4-1 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 package segment → 80425-0042-02. 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

📗 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 $5.91 / 60 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
80425-0042-01 80425-0042-1 Main listing 30 TABLET in 1 BOTTLE 2006-07-19 — Active
80425-0042-02 You're viewing this 60 TABLET in 1 BOTTLE 2006-07-19 — Active
80425-0042-03 80425-0042-3 90 TABLET in 1 BOTTLE 2006-07-19 — Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 tablet in 1 bottle.
How does this package differ from NDC 80425-0042-01?
Both are Meloxicam 7.5 mg Tablet — the drug itself is identical. This page's package is the 60-count one, while NDC 80425-0042-01 is the 30 tablets package.
What NDC number is used to bill for this package of Meloxicam 7.5 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 7.5 mg 11788-0046-01 AiPing 100 tablets $0.017 AB Availability likely —
meloxicam 7.5 mg 29300-0124-01 Unichem 100 tablets $0.017 AB Availability likely —
Meloxicam 7.5 mg 50268-0525-15 AvPAK 50 tablets $0.017 AB Availability likely —
Meloxicam 7.5 mg 61442-0126-10 Carlsbad 1000 tablets $0.017 AB Availability likely —
Meloxicam 7.5 mg 62135-0715-18 Chartwell 180 tablets $0.017 AB Availability likely —
Meloxicam 7.5 mg 65862-0097-01 Aurobindo 100 tablets $0.017 — Availability likely —
meloxicam 7.5 mg 68382-0050-01 Zydus 100 tablets $0.017 AB Availability likely —
Meloxicam 7.5 mg 69097-0158-07 Cipla 100 tablets $0.017 AB Availability likely —
Meloxicam 7.5 mg 76282-0152-01 Exelan 100 tablets $0.017 AB Availability likely —
meloxicam 7.5 mg 82009-0129-05 Quallent 500 tablets $0.017 AB Availability likely —
Meloxicam 7.5 mg 00615-8040-30 NCS 30 tablets — AB Discontinued —
Meloxicam 7.5 mg 11788-0098-00 AiPing 83000 tablets — AB FDA listed —
Meloxicam 7.5 mg 31722-0226-01 Camber 100 tablets — AB FDA listed —
meloxicam 7.5 mg 35356-0808-30 Quality 30 tablets — AB FDA listed —
meloxicam 7.5 mg 42708-0093-30 QPharma, 30 tablets — AB FDA listed —
Meloxicam 7.5 mg 43063-0395-14 PD-Rx 14 tablets — AB FDA listed —
Meloxicam 7.5 mg 50090-6803-01 A-S 14 tablets — AB FDA listed —
meloxicam 7.5 mg 50090-6832-00 A-S 90 tablets — AB FDA listed —
meloxicam 7.5 mg 50090-7495-00 A-S 90 tablets — AB FDA listed —
Meloxicam 7.5 mg 50090-7875-00 A-S 90 tablets — AB FDA listed —
Meloxicam 7.5 mg 51407-0610-10 Golden 1000 tablets — AB FDA listed —
Meloxicam 7.5 mg 51655-0177-25 Northwind 60 tablets — AB FDA listed —
meloxicam 7.5 mg 51655-0731-25 Northwind 60 tablets — AB FDA listed —
Meloxicam 7.5 mg 53225-3075-01 Terrain 30 tablets — AB FDA listed —
meloxicam 7.5 mg 55289-0272-14 PD-Rx 14 tablets — AB FDA listed —
meloxicam 7.5 mg 60760-0404-07 St. 7 tablets — AB FDA listed —
meloxicam 7.5 mg 60760-0448-07 St. 7 tablets — AB FDA listed —
Meloxicam 7.5 mg 61919-0434-14 Direct 14 tablets — AB Discontinued —
meloxicam 7.5 mg 63187-0082-10 Proficient 10 tablets — AB FDA listed —
Meloxicam 7.5 mg 63629-3248-00 Bryant 120 tablets — AB Discontinued —
meloxicam 7.5 mg 65841-0050-01 Zydus 100 tablets — AB FDA listed —
meloxicam 7.5 mg 67046-0057-03 Coupler 30 tablets — AB FDA listed —
meloxicam 7.5 mg 68071-1994-02 NuCare 20 tablets — AB FDA listed —
meloxicam 7.5 mg 68788-7726-00 Preferred 100 tablets — AB FDA listed —
meloxicam 7.5 mg 68788-8758-00 Preferred 100 tablets — AB FDA listed —
meloxicam 7.5 mg 70518-0031-00 REMEDYREPACK 30 tablets — AB FDA listed —
meloxicam 7.5 mg 70518-0039-05 REMEDYREPACK 15 tablets — AB FDA listed —
Meloxicam 7.5 mg 70518-2631-00 REMEDYREPACK 60 tablets — AB Discontinued —
meloxicam 7.5 mg 70518-3023-00 REMEDYREPACK 30 tablets — AB FDA listed —
Meloxicam 7.5 mg 71205-0923-00 Proficient 100 tablets — AB FDA listed —
meloxicam 7.5 mg 71335-0406-00 Bryant 120 tablets — AB FDA listed —
meloxicam 7.5 mg 71335-2080-00 Bryant 120 tablets — AB FDA listed —
Meloxicam 7.5 mg 71335-3056-01 Bryant 500 tablets — AB FDA listed —
meloxicam 7.5 mg 71610-0516-60 Aphena 90 tablets — AB FDA listed —
Meloxicam 7.5 mg 71610-0583-15 Aphena 15 tablets — AB FDA listed —
Meloxicam 7.5 mg 71610-0881-30 Aphena 30 tablets — AB FDA listed —
Meloxicam 7.5 mg 72789-0402-30 PD-Rx 30 tablets — AB FDA listed —
Meloxicam 7.5 mg 72789-0446-14 PD-Rx 14 tablets — AB FDA listed —
Meloxicam 7.5 mg 72865-0137-01 XLCare 100 tablets — AB FDA listed —
Meloxicam 7.5 mg 72865-0332-01 XLCare 100 tablets — AB FDA listed —
meloxicam 7.5 mg 76420-0043-15 Asclemed 15 tablets — AB FDA listed —
Meloxicam 7.5 mg 76420-0325-00 Asclemed 1000 tablets — AB FDA listed —
Meloxicam 7.5 mg 80425-0041-01 Advanced 30 tablets — AB FDA listed —
Meloxicam 7.5 mgthis 80425-0042-02 Advanced 60 tablets — AB FDA listed —
Meloxicam 7.5 mg 80425-0043-01 Advanced 30 tablets — AB FDA listed —
Meloxicam 7.5 mg 80425-0558-01 Advanced 30 tablets — AB FDA listed —
Meloxicam 7.5 mg 80425-0559-01 Advanced 30 tablets — AB FDA listed —
Meloxicam 7.5 mg 80425-0563-01 Advanced 30 tablets — AB FDA listed —
Meloxicam 7.5 mg 82461-0719-30 Medcore 30 tablets — AB FDA listed —
meloxicam 7.5 mg 85509-1124-01 PHOENIX 100 tablets — AB FDA listed —
Meloxicam 7.5 mg 68180-0501-01 Lupin 100 tablets — — Discontinued —
meloxicam 7.5 mg 85534-0019-00 HAWAII 30 tablets — AB FDA listed —
meloxicam 7.5 mg 67046-1342-03 Coupler 30 tablets — AB FDA listed —
Meloxicam 7.5 mg 72189-0683-30 Direct_Rx 30 tablets — AB FDA listed —
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

🏛️
2006
On the market since
Jul 2006
📍
2026
Currently FDA-listed
20 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

LabelerAdvanced Rx of Tennessee, LLC
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA077921 (ANDA)
Labeler code80425
First marketedJul 2006
Product typeHuman Prescription Drug
Portfolio280 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 146 words ▾

Boxed Warning WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1)]. Meloxicam is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.1)].

Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2)].

🎯 Indications and Usage 94 words ▾

1. Indications and Usage Section 1 INDICATIONS AND USAGE

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

1.2Rheumatoid Arthritis (RA) Meloxicam tablets are 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 are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh ≥60 kg [see Dosage and Administration (2.4) and Clinical Studies (14.2)].

⏱️ Dosage and Administration ~2 min read ▾

2. Dosage and Administration Section 2 DOSAGE AND ADMINISTRATION

2.1General Dosing Instructions Carefully consider the potential benefits and risks of meloxicam tablets and other treatment options before deciding to use meloxicam tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)]. After observing the response to initial therapy with meloxicam tablets, adjust the dose to suit an individual patient's needs.

In adults, the maximum recommended daily oral dose of meloxicam tablets are 15 mg regardless of formulation. In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)]. Meloxicam tablets 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 tablets 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 tablets is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.

2.4Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course For the treatment of juvenile rheumatoid arthritis, the recommended oral dose of meloxicam tablets is 7.5 mg once daily in children who weigh ≥60 kg. There was no additional benefit demonstrated by increasing the dose above 7.5 mg in clinical trials. Meloxicam tablets should not be used in children who weigh <60 kg.

2.5Renal Impairment The use of meloxicam in subjects with severe renal impairment is not recommended. In patients on hemodialysis, the maximum dosage of meloxicam is 7.5 mg per day [see Clinical Pharmacology (12.3)].

2.6Non-Interchangeability with Other Formulations of Meloxicam Meloxicam tablets have not shown equivalent systemic exposure to other approved formulations of oral meloxicam. Therefore, meloxicam tablets are not interchangeable with other formulations of oral meloxicam product even if the total milligram strength is the same. Do not substitute similar dose strengths of meloxicam tablets with other formulations of oral meloxicam product.

💊 Dosage Forms and Strengths 52 words ▾

3. Dosage Forms and Strengths Meloxicam Tablets, USP: 7.5 mg: yellow, round-shaped, flat beveled edge, uncoated tablets debossed with ‘ZC’ and ‘25’ on one side and plain on other side 15 mg: yellow, round-shaped, flat beveled edge, uncoated tablet debossed with ‘ZC’ and ‘26’ on one side and plain on other side

⛔ Contraindications 86 words ▾

4. Contraindications Section 4 CONTRAINDICATIONS Meloxicam is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [see Warnings and Precautions (5.7, 5.9) ] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7,5.8) ] 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

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, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.

However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

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

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, such as meloxicam, increases the risk of serious gastrointestinal (GI) events [see Warnings and Precautions (5.2)]. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.

NSAIDs are contraindicated in the setting of CABG [see Contraindications (4)]. Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients.

Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up. Avoid the use of meloxicam in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If meloxicam is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

5.2Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs, including meloxicam, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, 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 occurred in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. However, even short-term NSAID therapy is not without risk. Risk Factors for GI Bleeding, Ulceration, and Perforation Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors.

Other facto… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6. Adverse Reactions The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Boxed Warning and Warnings and Precautions (5.1) ] GI Bleeding, Ulceration, and Perforation [see Boxed Warning and Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.3) ] Hypertension [see Warnings and Precautions (5.4) ] Heart Failure and Edema [see Warnings and Precautions (5.5) ] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.6) ] Anaphylactic Reactions [see Warnings and Precautions (5.7) ] Serious Skin Reactions [see Warnings and Precautions (5.9) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.10)] Fetal Toxicity [see Warnings and Precautions (5.11)] Hematologic Toxicity [see Warnings and Precautions (5.12) ]

6.1Clinical Trials Experience 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. 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. Header$ 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

2.6Edema1 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 Rash2 2.5 2.6 0.6 2.0 1WHO preferred terms edema, edema dependent, edema peripheral, and edema legs combined 2WHO preferred terms rash, rash erythematous, and rash maculo-papular combined Header$ Placebo Meloxicam 7.5 mg daily Meloxicam 15 mg daily No. of Patients 469 481 477 Gastrointestinal Disorders 14.1 18.9

16.8Abdominal pain NOS2 0.6 2.9

2.3Dyspeptic signs and symptoms1 3.8 5.8

4.0Nausea2 2.6 3.3

3.8General Disorders and Administration Site Conditions Influenza-like illness2 2.1 2.9

2.3Infection and Infestations Upper respiratory tract infections-pathogen class unspecified1 4.1 7.0

6.5Musculoskeletal and Connective Tissue Disorders Joint related signs and symptoms 1 1.9 1.5

2.3Nervous System Disorders Headaches NOS2 6.4 6.4

5.5Skin and Subcutaneous Tissue Disorders Rash NOS2 1.7 1.0… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7. Drug Interactions See Table 3 for clinically significant drug interactions with meloxicam. See also Warnings and Precautions (5.2, 5.6, 5.12) and Clinical Pharmacology (12.3).

Drugs that Interfere with Hemostasis Clinical Impact: Meloxicam and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of meloxicam and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis.

Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of meloxicam with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see Warnings and Precautions (5.12) ]. Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone.

In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see Warnings and Precautions (5.2) ]. Intervention: Concomitant use of meloxicam and low dose aspirin or analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see Warnings and Precautions (5.11) ]. Meloxicam is not a substitute for low dose aspirin for cardiovascular protection.

ACE Inhibitors, Angiotensin Receptor Blockers, or Beta-Blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.

Intervention: During concomitant use of meloxicam and ACE inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. During concomitant use of meloxicam and ACE inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [see Warnings and Precautions (5.6) ]. When these drugs are administered concomitantly, patients should be adequately hydrated.

Assess renal function at the beginning of the concomitant treatment and periodically thereafter. Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID 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. Intervention: During concomitant use of meloxicam with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see Warnings and Precautions (5.6) ].

Lithium Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis [see Clinical Pharmaco… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8. Use in Specific Populations

8.1Pregnancy Risk Summary Use of NSAIDs, including meloxicam, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of meloxicam use between about 20 and 30 weeks of gestation, and avoid meloxicam use at about 30 weeks of gestation and later in pregnancy (see Clinical Considerations, Data). Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including meloxicam, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.

Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies, embryofetal death was observed in rats and rabbits treated during the period of organogenesis with meloxicam at oral doses equivalent to 0.65- and 6.5-times the maximum recommended human dose (MRHD) of meloxicam.

Increased incidence of septal heart defects were observed in rabbits treated throughout embryogenesis with meloxicam at an oral dose equivalent to 78-times the MRHD. In pre- and post-natal reproduction studies, there was an increased incidence of dystocia, delayed parturition, and decreased offspring survival at 0.08-times MRHD of meloxicam. No teratogenic effects were observed in rats and rabbits treated with meloxicam during organogenesis at an oral dose equivalent to 2.6 and 26-times the MRHD [see Data].

Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors, such as meloxicam, resulted in increased pre- and post-implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development.

In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including meloxicam, can cause premature closure of the fetal ductus arteriosus (see Data). Oligohydramnios/Neonatal Renal Impairment: If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible.

If meloxicam treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue meloxicam and follow up according to clinical practice (see Data). Labor or Delivery There are no studies on the effects of meloxicam during labor or delivery.

In animal studies, NSAIDs, including meloxicam, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Human Data Premature Closure of Fetal Ductus Arteriosus: Published literature reports that the use of NSAIDs at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment: Published s… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 193 words ▾

10. Overdosage Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred.

Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [see Warnings and Precautions (5.1, 5.2, 5.4, 5.6)]. Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes.

Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. There is limited experience with meloxicam overdosage.

Cholestyramine is known to accelerate the clearance of meloxicam. 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 overdosage.

For additional information about overdosage treatment, call a poison control center (1-800-222-1222).

🧬 Clinical Pharmacology ~3 min read ▾

12. Clinical Pharmacology

12.1Mechanism of Action Meloxicam has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of meloxicam, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Meloxicam is a potent inhibitor of prostaglandin synthesis in vitro.

Meloxicam concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation.

Because meloxicam is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

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 Cmax 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 oral suspension doses of 7.5 mg/5 mL and 15 mg/10 mL have been found to be bioequivalent to meloxicam 7.5 mg and 15 mg capsules, respectively. Meloxicam capsules have been shown to be bioequivalent to meloxicam tablets. Pharmacokinetic Parameters (% CV) Steady State Single Dose Healthy male adults (Fed)2 Elderly males (Fed)2 Elderly females (Fed)2 Renal failure (Fasted) Hepatic insufficiency (Fasted) 7.5 mg3 tablets 15 mg capsules 15 mg capsules 15 mg capsules 15 mg capsules N 18 5 8 12 12 Cmax [µg/mL] 1.05 (20) 2.3 (59) 3.2 (24) 0.59 (36) 0.84 (29) tmax [h] 4.9 (8) 5 (12) 6 (27) 4 (65) 10 (87) t½ [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) Vz/f4 [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 Vz/f = Dose/(AUC•Kel) 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., Cmax) being increased by approximately 22% while the extent of absorption (AUC) was unchanged.

The time to maximum concentration (Tmax) was achieved between 5 and 6 hours. In comparison, neither the AUC nor the Cmax values for meloxicam suspension were affected following a similar high fat meal, while mean Tmax 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.

Eli… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 94 words ▾

16. How Supplied/Storage and Handling Meloxicam Tablets USP, 7.5 mg are yellow, round-shaped, flat beveled edge, uncoated tablets debossed with 'ZC' and '25' on one side and plain on other side and are supplied as follows: Bottles of 30 Tablets NDC 80425-0042-01 Bottles of 60 Tablets NDC 80425-0042-02 Bottles of 90 Tablets NDC 80425-0042-03 Storage Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Keep meloxicam tablets in a dry place.

Dispense tablets in a tight container. Keep this and all medications out of the reach of children.

📋 Description 138 words ▾

11. Description Section Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each yellow meloxicam tablet 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)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula.

Meloxicam, USP is a pale yellow powder, practically insoluble in water, slightly soluble in acetone, soluble in dimethylformamide, very slightly soluble in ethanol (96 %) and 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.

Each meloxicam tablet, USP intended for oral administration contains 7.5 mg or 15 mg of meloxicam. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate. Structure

💬 Medication Guide ~3 min read ▾

Medication Guide Section Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death . This risk may happen early in treatment and may increase: ○ with increasing doses of NSAIDs ○ with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to.

You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: ○ anytime during use ○ without warning symptoms ○ that may cause death The risk of getting an ulcer or bleeding increases with: ○ past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs ○ taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs" ○ increasing doses of NSAIDs ○ older age ○ longer use of NSAIDs ○ poor health o smoking ○ advanced liver disease ○ drinking alcohol ○ bleeding problems NSAIDs should only be used: ○ exactly as prescribed ○ at the lowest dose possible for your treatment ○ for the shortest time needed What are NSAIDs?

NSAIDs 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 NSAIDs? Do not take NSAIDs: if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. right before or after heart bypass surgery.

Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems have high blood pressure have asthma are pregnant or plan to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby.

You should not take NSAIDs after 30 weeks of pregnancy. are breastfeeding or plan to breast feed. Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects.

Do not start taking any new medicine without talking to your healthcare provider first. What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including: See "What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?" new or worse high blood pressure heart failure liver problems including liver failure kidney problems including kidney failure low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions Other side effects of NSAIDs include : stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms: shortness of breath or trouble breathing slurred speech chest pain swelling of the face or throat weakness in one part or side of your body Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: nausea vomit blood more tired or weaker than usual there is blood in your bowel movement or it is black and sticky like tar diarrhea unusual weight gain itching skin rash or blisters with fever your skin or eyes look yellow swelling of the arms, legs, hands and feet indigestion or stomach… [Excerpted — this section continues on DailyMed.]

🔬 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 140 words ▾

13. Non Clinical 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-times, respectively, the maximum recommended human dose [MRHD] of 15 mg/day meloxicam based on body surface area [BSA] 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-times greater, respectively, than the MRHD based on BSA comparison).

📄 Package Label / Principal Display Panel 11 words ▾

Package Label Principal Display Panel label 1 label 2 label 3

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

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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 Advanced Rx of 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 2 other package presentations of this same product, including 30 tablets (80425-0042-01), 90 tablets (80425-0042-03). 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?
Advanced Rx of 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.
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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.
← 80425-0041-01 · Advanced 80425-0043-01 · Advanced →
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.