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Meloxicam 15 mg Tablet, 60-count — NDC 70518-1630-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Meloxicam 15 mg Tablet, 60-count — NDC 70518-1630-2 (Billing 70518-1630-02)

by REMEDYREPACK INC. · 60 TABLET in 1 BOTTLE, PLASTIC

This is a package of 60 tablets of Meloxicam 15 mg Tablet from REMEDYREPACK INC., no longer marketed (first marketed Nov 2018), no longer in the FDA NDC Directory.

NDC 70518-1630-02
🏷️ FDA NDC (as labeled) 70518-1630-2 billing pads the package segment with a zero
This package
Contains60-count Pack sizes7 compare ↓
Product page 70518-1630-00 Also comes in: 10 tablets 70518-1630-5 14 tablets 70518-1630-3 30 tablets 70518-1630-0 30 tablets 70518-1630-6 45 tablets 70518-1630-4 100 tablets 70518-1630-8
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 3, 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70518-1630-2
Product NDC 70518-1630
11-digit billing NDC 70518163002
RxCUI 152695
UNII VG2QF83CGL
Application # ANDA077929
SPL Set ID 385b7cf4-976a-4a58-9ebc-def8b6e78b75
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 Discontinued
FDA listing status Discontinued by firm
Marketing start 2018-11-05
Route ORAL
Dosage form TABLET
Substance MELOXICAM
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 152695
Why two NDCs? The FDA registers this code as 70518-1630-2 — 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 → 70518-1630-02. 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

📖 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 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 tablets 14 tablets 30 tablets 30 tablets 45 tablets 100 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
70518-1630-02 You're viewing this 60 TABLET in 1 BOTTLE, PLASTIC 2022-06-14 — Discontinued by firm
70518-1630-03 70518-1630-3 14 TABLET in 1 BOTTLE, PLASTIC 2022-11-09 — Active
70518-1630-00 70518-1630-0 Main listing 30 TABLET in 1 BOTTLE, PLASTIC 2018-11-05 — Discontinued by firm
70518-1630-04 70518-1630-4 45 TABLET in 1 BOTTLE, PLASTIC 2023-05-22 — Discontinued by firm
70518-1630-05 70518-1630-5 10 TABLET in 1 BOTTLE, PLASTIC 2023-12-18 — Discontinued by firm
70518-1630-06 70518-1630-6 30 TABLET in 1 BLISTER PACK 2024-01-02 — Discontinued by firm
70518-1630-08 70518-1630-8 100 TABLET in 1 BOTTLE, PLASTIC 2025-10-06 — Active

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 tablet in 1 bottle, plastic.
How does this package differ from NDC 70518-1630-05?
Both are Meloxicam 15 mg Tablet — the drug itself is identical. This page's package is the 60-count one, while NDC 70518-1630-05 is the 10 tablets package.
What NDC number is used to bill for this package of Meloxicam 15 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Meloxicam 15 mg 11788-0047-01 AiPing 100 tablets $0.018 AB Availability likely —
meloxicam 15 mg 29300-0125-01 Unichem 100 tablets $0.018 AB Availability likely —
Meloxicam 15 mg 50268-0526-15 AvPAK 50 tablets $0.018 AB Availability likely —
Meloxicam 15 mg 60687-0199-01 American 100 tablets $0.018 AB Availability likely —
Meloxicam 15 mg 61442-0127-10 Carlsbad 1000 tablets $0.018 AB Availability likely —
Meloxicam 15 mg 62135-0716-18 Chartwell 180 tablets $0.018 AB Availability likely —
meloxicam 15 mg 68382-0051-01 Zydus 100 tablets $0.018 AB Availability likely —
Meloxicam 15 mg 69097-0159-07 Cipla 100 tablets $0.018 AB Availability likely —
Meloxicam 15 mg 76282-0153-01 Exelan 100 tablets $0.018 AB Availability likely —
meloxicam 15 mg 82009-0130-05 Quallent 500 tablets $0.018 AB Availability likely —
Meloxicam 15 mg 00615-8124-39 NCS 30 tablets — AB FDA listed —
Meloxicam 15 mg 11788-0099-00 AiPing 83000 tablets — AB FDA listed —
Meloxicam 15 mg 31722-0227-01 Camber 100 tablets — AB FDA listed —
meloxicam 15 mg 42708-0007-30 QPharma, 30 tablets — AB FDA listed —
Meloxicam 15 mg 43063-0396-07 PD-Rx 7 tablets — AB FDA listed —
meloxicam 15 mg 43063-0401-06 PD-Rx 6 tablets — AB FDA listed —
Meloxicam 15 mg 43353-0979-30 Aphena 30 tablets — AB FDA listed —
Meloxicam 15 mg 49999-0869-15 Quality 15 tablets — AB Discontinued —
meloxicam 15 mg 50090-0986-00 A-S 7 tablets — AB FDA listed —
meloxicam 15 mg 50090-4896-00 A-S 90 tablets — AB FDA listed —
meloxicam 15 mg 50090-5339-00 A-S 7 tablets — AB FDA listed —
meloxicam 15 mg 50090-5340-00 A-S 90 tablets — AB FDA listed —
Meloxicam 15 mg 50090-6671-00 A-S 7 tablets — AB FDA listed —
Meloxicam 15 mg 50090-6672-00 A-S 90 tablets — AB FDA listed —
Meloxicam 15 mg 51407-0611-10 Golden 1000 tablets — AB FDA listed —
Meloxicam 15 mg 51655-0571-26 Northwind 90 tablets — AB FDA listed —
meloxicam 15 mg 51655-0577-26 Northwind 90 tablets — AB FDA listed —
Meloxicam 15 mg 53225-3015-01 Terrain 30 tablets — AB FDA listed —
meloxicam 15 mg 60760-0419-07 St. 7 tablets — AB FDA listed —
Meloxicam 15 mg 60760-0653-07 St. 7 tablets — AB FDA listed —
Meloxicam 15 mg 61919-0469-30 Direct 30 tablets — AB FDA listed —
meloxicam 15 mg 63187-0083-10 Proficient 10 tablets — AB FDA listed —
Meloxicam 15 mg 63629-2019-01 Bryant 1000 tablets — AB FDA listed —
meloxicam 15 mg 63629-3328-00 Bryant 20 tablets — AB FDA listed —
meloxicam 15 mg 65841-0051-01 Zydus 100 tablets — AB FDA listed —
Meloxicam 15 mg 65862-0098-01 Aurobindo 100 tablets — AB FDA listed —
meloxicam 15 mg 67046-0891-03 Coupler 30 tablets — AB FDA listed —
Meloxicam 15 mg 67296-1317-03 Redpharm 30 tablets — AB Discontinued —
meloxicam 15 mg 68071-1993-03 NuCare 30 tablets — AB FDA listed —
Meloxicam 15 mg 68071-2184-03 NuCare 30 tablets — AB FDA listed —
meloxicam 15 mg 68071-3030-05 NuCare 15 tablets — AB FDA listed —
meloxicam 15 mg 68788-7904-01 Preferred 15 tablets — AB FDA listed —
meloxicam 15 mg 68788-8801-00 Preferred 100 tablets — AB FDA listed —
Meloxicam 15 mg 70518-0200-00 REMEDYREPACK 30 tablets — AB FDA listed —
meloxicam 15 mg 70518-0394-00 REMEDYREPACK 30 tablets — AB FDA listed —
Meloxicam 15 mgthis 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

🏛️
2018
On the market since
Nov 2018
📍
2026
Currently FDA-listed
8 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.

What it looks like

Color yellow
ShapeRound
ImprintCIPLA;159
Size1 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 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 QU7E2XA9TG
    Sodium stearate is a salt derived from stearic acid, a natural fatty substance. It acts as a lubricant and binder in tablets and capsules, helping the medicine hold together and flow smoothly during manufacturing.

3 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.

Manufacturer & labeler

LabelerREMEDYREPACK INC.
Application holderCIPLA LTD
FDA applicationANDA077929 (ANDA)
Labeler code70518
First marketedNov 2018
Product typeHuman Prescription Drug
Portfolio1,527 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

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

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 ) ].

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning . 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 ( 5.1 ) Meloxicam is contraindicated in the setting of coronary artery bypass graft (CABG) surgery ( 4, 5.1 ) 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 ( 5.2 )

🎯 Indications and Usage 120 words ▾

1 INDICATIONS AND USAGE Meloxicam is a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) (1.1) Rheumatoid Arthritis (RA) (1.2) Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3)

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

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

1.3Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course Meloxicam is 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 Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals ( 2.1 ) OA (2.2) and RA (2.3) : Starting dose: 7.5 mg once daily Dose may be increased to 15 mg once daily JRA (2.4) : 7.5 mg once daily in children ≥60 kg Meloxicam tablets are not interchangeable with approved formulations of oral meloxicam even if the total milligram strength is the same ( 2.6 )

2.1General Dosing Instructions Carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. 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, adjust the dose to suit an individual patient's needs.

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

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

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

2.4Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course For the treatment of juvenile rheumatoid arthritis, the recommended oral dose of meloxicam 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 37 words ▾

3 DOSAGE FORMS AND STRENGTHS Meloxicam tablets: 7.5 mg and 15 mg ( 3 ) Meloxicam tablets, USP: 15 mg: yellow coloured, round, flat bevelled tablets, debossed with "CIPLA" on one side and "159" on the other.

⛔ Contraindications 134 words ▾

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 ) ] Known hypersensitivity to meloxicam or any components of the drug product ( 4 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4) In the setting of CABG surgery ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop ( 5.3 ) Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure ( 5.4 , 7 ) Heart Failure and Edema : Avoid use of meloxicam in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure ( 5.5) Renal Toxicity : Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia.

Avoid use of meloxicam in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function ( 5.6 ) Anaphylactic Reactions : Seek emergency help if an anaphylactic reaction occurs ( 5.7 ) Exacerbation of Asthma Related to Aspirin Sensitivity : Meloxicam is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) ( 5.8 ) Serious Skin Reactions : Discontinue meloxicam at first appearance of skin rash or other signs of hypersensitivity ( 5.9 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue meloxicam and evaluate clinically ( 5.10 ) Fetal Toxicity: Limit use of NSAIDs, including meloxicam, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction.

Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus ( 5.11 , 8.1 ) Hematologic Toxicity : Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia ( 5.12 , 7 )

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 t… [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 ) ] Most common (≥5% and greater than placebo) adverse events in adults are diarrhea, upper respiratory tract infections, dyspepsia, and influenza-like symptoms ( 6.1 ) Adverse events observed in pediatric studies were similar in nature to the adult clinical trial experience ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Limited, India at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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. Table 1a Adverse Events (%) Occurring in ≥2% of Meloxicam Patients in a 12-Week Osteoarthritis Placebo- and Active-Controlled Trial 1 WHO preferred terms edema, edema dependent, edema peripheral, and edema legs combined 2 WHO preferred terms rash, rash erythematous, and rash maculo-papular combined Placebo Meloxicam 7.5 mg daily Meloxicam 15 mg daily Diclofenac 100 mg daily No. of Patients 157 154 156 153 Gastrointestinal 17.2 20.1 17.3

28.1Abdominal pain 2.5 1.9 2.6

1.3Diarrhea 3.8 7.8 3.2

9.2Dyspepsia 4.5 4.5 4.5

6.5Flatulence 4.5 3.2 3.2

3.9Nausea 3.2 3.9 3.8

7.2Body as a Whole Accident household 1.9 4.5 3.2

2.6Edema 1 2.5 1.9 4.5

3.3Fall 0.6 2.6 0.0

1.3Influenza-like symptoms 5.1 4.5 5.8

2.6Central and Peripheral Nervous System Dizziness 3.2 2.6 3.8

2.0Headache 10.2 7.8 8.3

5.9Respiratory Pharyngitis 1.3 0.6 3.2

1.3Upper respiratory tract infection 1.9 3.2 1.9

3.3Skin Rash 2 2.5 2.6 0.6

2.0Table 1b Adverse Events (%) Occurring i… [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 ). Table 3 Clinically Significant Drug Interactions with Meloxicam 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 ( 5.12 ) ]. 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, coadministration 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 attr… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Infertility : NSAIDs are associated with reversible infertility. Consider withdrawal of meloxicam in women who have difficulties conceiving ( 8.3 )

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

🤰 Pregnancy ~3 min read ▾

5.9Serious Skin Reactions NSAIDs, including meloxicam, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.NSAIDs can also cause fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening. These serious events may occur without warning.

Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of meloxicam tablets at the first appearance of skin rash or any other sign of hypersensitivity. Meloxicam tablets is contraindicated in patients with previous serious skin reactions to NSAIDs [ see Contraindications ( 4 ) ].

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

🧒 Pediatric Use 47 words ▾

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

🧓 Geriatric Use 67 words ▾

8.5Geriatric Use Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [ see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.6 , 5.14 ) ].

🆘 Overdosage 200 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 C max was achieved within four to five hours after a 7.5 mg meloxicam tablet was taken under fasted conditions, indicating a prolonged drug absorption. With multiple dosing, steady-state concentrations were reached by Day 5. A second meloxicam concentration peak occurs around 12 to 14 hours post-dose suggesting biliary recycling.

Meloxicam capsules have been shown to be bioequivalent to meloxicam tablets. Table 4 Single Dose and Steady-State Pharmacokinetic Parameters for Oral 7.5 mg and 15 mg Meloxicam (Mean and % CV)1 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 mg 3 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) t 1/2 [h] 20.1 (29) 21 (34) 24 (34) 18 (46) 16 (29) CL/f [mL/min] 8.8 (29) 9.9 (76) 5.1 (22) 19 (43) 11 (44) V z /f 4 [L] 14.7 (32) 15 (42) 10 (30) 26 (44) 14 (29) 1 The parameter values in the table are from various studies 2 not under high fat conditions 3 Meloxicam tablets 4 V z /f = Dose/(AUC•K el ) Food and Antacid Effects Administration of meloxicam capsules following a high fat breakfast (75 g of fat) resulted in mean peak drug levels (i.e., C max ) being increased by approximately 22% while the extent of absorption (AUC) was unchanged.

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

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

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

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

Elimination Metabo… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 99 words ▾

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.

📦 How Supplied / Storage and Handling 161 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Meloxicam tablets, USP 15 mg are yellow coloured, round, flat bevelled tablets, debossed with "CIPLA" on one side and "159" on the other. Meloxicam tablets, USP 15 mg are available as follows: NDC: 70518-1630-00 NDC: 70518-1630-01 NDC: 70518-1630-02 NDC: 70518-1630-03 NDC: 70518-1630-04 NDC: 70518-1630-05 NDC: 70518-1630-06 NDC: 70518-1630-07 NDC: 70518-1630-08 PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 60 in 1 BOTTLE PLASTIC PACKAGING: 14 in 1 BOTTLE PLASTIC PACKAGING: 45 in 1 BOTTLE PLASTIC PACKAGING: 10 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 20 in 1 BOTTLE PLASTIC PACKAGING: 100 in 1 BOTTLE PLASTIC Store at 20°C to 25°C (68°F 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.

Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

📋 Description 147 words ▾

11 DESCRIPTION Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam, USP for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N -(5-methyl-2-thiazolyl)-2 H -1,2-benzothiazine-3-carboxamide-1,1-dioxide.

The molecular weight is 351.4. Its empirical formula is C 14 H 13 N 3 O 4 S 2 and it has the following structural formula: Meloxicam is a pale 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, USP.

The inactive ingredients in meloxicam tablets, USP include starch, microcrystalline cellulose, lactose anhydrous, colloidal silicon dioxide, sodium citrate dihydrate, magnesium stearate. structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families or their caregivers of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately [ see Warnings and Precautions ( 5.1 ) ].

Gastrointestinal Bleeding, Ulceration, and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their healthcare provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for the signs and symptoms of GI bleeding [ see Warnings and Precautions ( 5.2 ) ]. Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms).

If these occur, instruct patients to stop meloxicam and seek immediate medical therapy [ see Warnings and Precautions ( 5.3 ) ]. Heart Failure and Edema Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [ see Warnings and Precautions ( 5.5 ) ]. Anaphylactic Reactions Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat).

Instruct patients to seek immediate emergency help if these occur [ see Contraindications ( 4 ) and Warnings and Precautions ( 5.7 ) ]. Serious Skin Reactions, including DRESS Advise patients to stop taking meloxicam immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible [ see Warnings and Precautions ( 5.9 ), 5.10 ) ]. Female Fertility Advise females of reproductive potential who desire pregnancy that NSAIDs, including meloxicam, may be associated with a reversible delay in ovulation [ see Use in Specific Populations ( 8.3 ) ].

Fetal Toxicity Inform pregnant women to avoid use of meloxicam and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with meloxicam is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours [ see Warnings and Precautions( 5.11 ) and Use in Specific Populations ( 8.1 ) ]. Avoid Concomitant Use of NSAIDs Inform patients that the concomitant use of meloxicam with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [ see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7 ) ].

Alert patients that NSAIDs may be present in "over the counter" medications for treatment of colds, fever, or insomnia. Use of NSAIDs and Low-Dose Aspirin Inform patients not to use low-dose aspirin concomitantly with meloxicam until they talk to their healthcare provider [ see Drug Interactions ( 7 ) ]. Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701 (724) 465-8762

💬 Medication Guide ~3 min read ▾

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 ○ older age ○ taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” ○ poor health ○ increasing doses of NSAIDs ○ advanced liver disease ○ longer use of NSAIDs ○ bleeding problems ○ smoking ○ drinking alcohol 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 about 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 ● there is blood in your bowel movement or it is black ● more tired or weaker than usual ● vomit blood ● diarrhea ● there is blood in your bowel movement or it is black and sticky like tar ● itching ● unusual weight gain ● your skin or eyes look yellow ● skin rash or blisters with fever ● indigestio… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 96 words ▾

8.3Females and Males of Reproductive Potential Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including meloxicam, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation.

Consider withdrawal of NSAIDs, including meloxicam, in women who have difficulties conceiving or who are undergoing investigation of infertility.

🧬 Pharmacokinetics ~3 min read ▾

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

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

Meloxicam capsules have been shown to be bioequivalent to meloxicam tablets. Table 4 Single Dose and Steady-State Pharmacokinetic Parameters for Oral 7.5 mg and 15 mg Meloxicam (Mean and % CV)1 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 mg 3 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) t 1/2 [h] 20.1 (29) 21 (34) 24 (34) 18 (46) 16 (29) CL/f [mL/min] 8.8 (29) 9.9 (76) 5.1 (22) 19 (43) 11 (44) V z /f 4 [L] 14.7 (32) 15 (42) 10 (30) 26 (44) 14 (29) 1 The parameter values in the table are from various studies 2 not under high fat conditions 3 Meloxicam tablets 4 V z /f = Dose/(AUC•K el ) Food and Antacid Effects Administration of meloxicam capsules following a high fat breakfast (75 g of fat) resulted in mean peak drug levels (i.e., C max ) being increased by approximately 22% while the extent of absorption (AUC) was unchanged.

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

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

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

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

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

Patients' peroxidase activity is probably responsible for the other two metabolites which account for 16% and 4% of the administered dose, respectively. All the four metabolites are not known to have any in vivo pharmacological activity. Excretion Meloxicam excretion is pre… [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 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis There was no increase in tumor incidence in long-term carcinogenicity studies in rats (104 weeks) and mice (99 weeks) administered meloxicam at oral doses up to 0.8 mg/kg/day in rats and up to 8.0 mg/kg/day in mice (up to 0.5- and 2.6-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).

📄 Recent Major Changes 13 words ▾

RECENT MAJOR CHANGES Warnings and Precautions, Serious Skin Reactions ( 5.9 ) 8/2024

📄 Package Label / Principal Display Panel 115 words ▾

DRUG: MELOXICAM GENERIC: meloxicam DOSAGE: TABLET ADMINSTRATION: ORAL NDC: 70518-1630-0 NDC: 70518-1630-1 NDC: 70518-1630-2 NDC: 70518-1630-3 NDC: 70518-1630-4 NDC: 70518-1630-5 NDC: 70518-1630-6 NDC: 70518-1630-7 NDC: 70518-1630-8 COLOR: yellow SHAPE: ROUND SCORE: No score SIZE: 10 mm IMPRINT: CIPLA;159 PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 60 in 1 BOTTLE PLASTIC PACKAGING: 14 in 1 BOTTLE PLASTIC PACKAGING: 45 in 1 BOTTLE PLASTIC PACKAGING: 10 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 20 in 1 BOTTLE PLASTIC PACKAGING: 100 in 1 BOTTLE PLASTIC ACTIVE INGREDIENT(S): MELOXICAM 15mg in 1 INACTIVE INGREDIENT(S): SODIUM STEARATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MM1 MM2 MM3 MM5 MM5 MM6 MM7 MM8 MM9

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

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

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

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 6 other package presentations of this same product, including 10 tablets (70518-1630-05), 14 tablets (70518-1630-03), 30 tablets (70518-1630-00). 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?
REMEDYREPACK INC. 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.
← 70518-1627-00 · REMEDYREPACK 70518-1635-00 · REMEDYREPACK →
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.