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Meloxicam 15 mg Tablet, 60-count — NDC 49999-0869-60 package photo

Meloxicam 15 mg Tablet, 60-count

by Quality Care Products LLC · 60 TABLET in 1 BOTTLE, PLASTIC (49999-869-60)
NDC 49999-0869-60
🏷️ FDA NDC (as labeled) 49999-869-60 billing pads the product segment with a zero
This package
Contains60-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.0985/unit — full pricing hub ↓
Also comes in: 15 tablets 49999-0869-15 30 tablets 49999-0869-30 90 tablets 49999-0869-90
Rx only Generic On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 49999-869-60
Product NDC 49999-869
11-digit billing NDC 49999086960
NCPDP billing unit EA — each (per item)
RxCUI 152695
UNII VG2QF83CGL
Application # ANDA077927
SPL Set ID aa28251e-cab0-49a2-bf3f-ad820b1432cf
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 2010-09-17
Marketing end 2027-01-31
Route ORAL
Dosage form TABLET
Substance MELOXICAM
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
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 49999-869-60 — 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 → 49999-0869-60. 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.

🏭 Manufacturer & labeler

LabelerQuality Care Products LLC
Application holderUNICHEM LABORATORIES LTD
FDA applicationANDA077927 (ANDA)
Labeler code49999
First marketedSep 2010
Product typeHuman Prescription Drug
Portfolio25 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.

🩺 Clinical

Label name MELOXICAM 15 MG TABLET Ingredient Meloxicam
📖 What it is MedlinePlus · NLM

Meloxicam is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). Meloxicam is also used to relieve the pain, tenderness, swelling, and stiffness caused by juvenile rheumatoid arthritis (a type of arthritis that affects children) in children 2 years of age and older. Meloxicam is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the body's production of a substance that...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Meloxicam treats pain and inflammation from osteoarthritis and rheumatoid arthritis in adults. It's also approved for juvenile rheumatoid arthritis in children — the oral suspensio...
  • What conditions is meloxicam actually used to treat?
  • Good news — you can take meloxicam with or without food, so whatever is easiest for you works fine. Taking it with a small snack can help if you find it bothers your stomach. It's...
  • Can I take meloxicam with food, and does it matter what time of day I take it?
📖 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.

💊 What it looks like

Color yellow
ShapeOval
ImprintU;L;15
Size12 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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.

🔁 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 mg 43353-0979-30 Aphena 30 tablets — AB FDA listed —
Meloxicam 15 mgthis 49999-0869-60 Quality 60 tablets — AB FDA listed —
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
Sep 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.

📊 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Meloxicam — the ingredient across all brands.

Top reported reactions

Pain4,833
Fatigue4,761
Arthralgia4,368
Nausea3,986
Headache3,473
Diarrhoea3,374
Dyspnoea2,782

Age at onset

Neonate4
Infant3
Child32
Adolescent92
Adult6,675
Elderly3,694

Reporter sex

57,978 reports
Male · 28%
Female · 72%
Unknown · 0%

Serious outcomes

Hospitalization13,874
Death3,734
Disabling2,342
Life-threatening2,125
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,286 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
49999-0869-15 15 TABLET in 1 BOTTLE, PLASTIC (49999-869-15) 2010-09-17 Discontinued by firm
49999-0869-30 30 TABLET in 1 BOTTLE, PLASTIC (49999-869-30) 2010-09-17 Active
49999-0869-60 You're viewing this 60 TABLET in 1 BOTTLE, PLASTIC (49999-869-60) 2010-09-17 Active
49999-0869-90 90 TABLET in 1 BOTTLE, PLASTIC (49999-869-90) 2010-09-17 Active

You're viewing one of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 49999-0869-60?
NDC 49999-0869-60 is a 60-count package — 60 tablet in 1 bottle, plastic.
What is the difference between NDC 49999-0869-60 and NDC 49999-0869-15?
Both are Meloxicam 15 mg Tablet — the drug itself is identical. NDC 49999-0869-60 is the 60-count package, while NDC 49999-0869-15 is the 15 tablets package.
What NDC number is used to bill for this package of Meloxicam 15 mg Tablet?
Bill NDC 49999-0869-60 — the 11-digit billing format is 49999086960. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 ✓ Available
Inactive ingredients (structured) ✓ 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 FDA registers it as 49999-869-60, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 49999-0869-60, written without dashes as 49999086960. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 49999-0869-60, the first segment (49999) is the labeler code FDA assigned to Quality Care Products LLC; the middle segment (0869) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but Quality Care Products LLC has reported a marketing end date of 2027-01-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 15 tablets (49999-0869-15), 30 tablets (49999-0869-30), 90 tablets (49999-0869-90). 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?
Quality Care Products 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 124 words ▾

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 (see WARNINGS and CLINICAL TRIALS ).

Meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ). 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 (see WARNINGS ).

🎯 Indications and Usage 54 words ▾

INDICATIONS AND USAGE 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 ). Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis.

⏱️ Dosage and Administration 162 words ▾

DOSAGE AND ADMINISTRATIONOsteoarthritis and Rheumatoid Arthritis 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 ). After observing the response to initial therapy with meloxicam, the dose should be adjusted to suit an individual patient's needs.

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. 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. The maximum recommended daily oral dose of meloxicam is 15 mg. Meloxicam may be taken without regard to timing of meals.

⛔ Contraindications 79 words ▾

CONTRAINDICATIONS Meloxicam is contraindicated in patients with known hypersensitivity 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 , Anaphylactoid Reactions , and PRECAUTIONS , Pre-existing Asthma ).

Meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

⚠️ Warnings ~3 min read ▾

WARNINGS Cardiovascular EffectsCardiovascular 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.

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 , Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and Perforation ). 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 (see CONTRAINDICATIONS ).

Hypertension NSAIDs, including meloxicam can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including meloxicam should be used with caution in patients with hypertension.

Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Congestive Heart Failure and Edema Fluid retention and edema have been observed in some patients taking NSAIDs. Meloxicam should be used with caution in patients with fluid retention, hypertension, or heart failure.

Gastrointestinal (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 3-6 months, and in about 2-4% 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.

NSAIDs should be prescribed 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 patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status.

Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population. To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible…

🤒 Adverse Reactions 4 words ▾

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🆘 Overdosage 212 words ▾

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 are usually limited to 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. In cases of acute overdose, gastric lavage followed by activated charcoal is recommended.

Gastric lavage performed more than one hour after overdose has little benefit in the treatment of overdose. Administration of activated charcoal is recommended for patients who present 1-2 hours after overdose. For substantial overdose or severely symptomatic patients, activated charcoal may be administered repeatedly.

Accelerated removal of meloxicam by 4 gm 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.

🧬 Clinical Pharmacology 154 words ▾

CLINICAL PHARMACOLOGY Mechanism of Action Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of meloxicam, like that of other NSAIDs, may be related to prostaglandin synthetase (cyclo-oxygenase) inhibition. Pharmacokinetics 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 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.

📦 How Supplied / Storage and Handling 96 words ▾

HOW SUPPLIED Meloxicam Tablets USP are available as light yellow, round, flat, uncoated tablets containing meloxicam 7.5 mg or as light yellow, oblong, biconvex, uncoated tablets containing meloxicam 15 mg. The 7.5 mg tablet is impressed with letter U and L on one side and tablet code 7.5 on the other side. The 15 mg tablet is impressed with letter U and L on one side and tablet code 15 on the other side.

Meloxicam Tablets USP 7.5 mg are available as follows: Meloxicam Tablets USP 15 mg are available as follows: 49999-869-15 49999-869-30 49999-869-60 49999-869-90

📋 Description 158 words ▾

DESCRIPTION Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each pastel yellow Meloxicam tablet 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)- 2H -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, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.

💬 Information for Patients ~3 min read ▾

Information for Patients Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed. Meloxicam, like other NSAIDs, 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 , Cardiovascular Effects ). Meloxicam, like other NSAIDs, 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 , Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and Perforation ). Meloxicam, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations 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. Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible. Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians.

Patients should be informed 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, patients should be instructed to stop therapy and seek immediate medical therapy. Patients should be informed of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat).

If these occur, patients should be instructed to seek immediate emergency help (see WARNINGS ). In late pregnancy, as with other NSAIDs, meloxicam should be avoided because it will cause premature closure of the ductus arteriosus. Laboratory Tests Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding.

Patients on long-term treatment with NSAIDs should have their CBC and a chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (e.g., eosinophilia, rash, etc.) or if abnormal liver tests persist or worsen, meloxicam should be discontinued. Drug InteractionsACE-inhibitors Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors.

This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE inhibitors. Aspirin When meloxicam is administered with aspirin (1000 g TID) to healthy volunteers, it tended to increase the AUC (10%) and C max (24%) of meloxicam. 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 o…

💬 Medication Guide ~3 min read ▾

MELOXICAM - meloxicam tablet Unichem Pharmaceuticals (USA), Inc. ---------- Meloxicam Tablets USP 7.5 mg and 15 mg Meloxicam Tablets USP 7.5 mg and 15 mg 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 serious 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 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 skin rash or blisters with fever unusual weight gain 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. NSAID medicines that need a prescription Revised: 02/2009Unichem Pharmaceuticals (USA), Inc.

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