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Oxaprozin 300 mg Capsule, 60-count — NDC 70512-0787-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Oxaprozin 300 mg Capsule, 60-count — NDC 70512-787-60 (Billing 70512-0787-60)

by SOLA Pharmaceuticals, LLC · 60 CAPSULE in 1 BOTTLE

This is a package of 60 capsules of Oxaprozin 300 mg Capsule from SOLA Pharmaceuticals, LLC, marketed since Dec 2025 and currently FDA-listed. It is this product's only package size.

NDC 70512-0787-60
🏷️ FDA NDC (as labeled) 70512-787-60 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70512-787-60
Product NDC 70512-787
11-digit billing NDC 70512078760
NCPDP billing unit EA — each (per item)
RxCUI 2668162
UNII MHJ80W9LRB
UPC 0370512787608
Application # NDA217927
SPL Set ID 450f5941-7f10-42fe-e063-6394a90a4803
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 NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-03
Route ORAL
Dosage form CAPSULE
Substance OXAPROZIN

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

GPI-14 66100065000120
GCN Seq No 085427
GCN 54905
HICL code 006620
Ingredient (HICL) Oxaprozin
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 OXAPROZIN 300 MG CAPSULE
FDB brand name Oxaprozin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 085427
  • GCN: 54905
  • GPI-14 (Medi-Span): 66100065000120
  • HICL (First Databank): 006620
  • AHFS class code: 28:08.04.04
  • RxCUI (RxNorm): 2668162
Why two NDCs? The FDA registers this code as 70512-787-60 — 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 → 70512-0787-60. 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) Propionic acid derivatives
How it works Cyclooxygenase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name OXAPROZIN 300 MG CAPSULE Ingredient Oxaprozin
📖 What it is MedlinePlus · NLM

Oxaprozin 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). Oxaprozin is also used to relieve pain, tenderness, swelling, and stiffness caused by juvenile rheumatoid arthritis in children 6 years of age and older. Oxaprozin is in a class of medications called nonsteroidal anti-inflammatory medications (NSAIDs). It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It relieves pain and inflammation from osteoarthritis, rheumatoid arthritis and juvenile rheumatoid arthritis. It is an NSAID, similar in type to ibuprofen or naproxen. It treats s...
  • It is taken by mouth, usually once a day. Follow your prescriber's directions and the label. Food may slow absorption a bit but does not change how much your body gets. Do not swit...
  • Stomach upset is the most common, including constipation, diarrhea, indigestion and nausea. Some people get a rash. Mention it to your doctor if these are bothersome or persist.
  • Get emergency help for chest pain, trouble breathing, weakness on one side or signs of severe allergy. Call right away for black or bloody stools, vomiting blood, severe stomach pa...
📖 Read our full Oxaprozin guide →
1
Nutrient depletion considerations

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

🧪 Full Oxaprozin 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.
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
70512-0787-60 You're viewing this Main listing 60 CAPSULE in 1 BOTTLE 2025-12-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Oxaprozin 300 mgthis 70512-0787-60 SOLA 60 capsules — — FDA listed —
Coxanto 300 mg 70512-0814-60 SOLA 60 capsules — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 white
ShapeCapsule
Imprint403
Size22 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 R75537T0T4
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
  • 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 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.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

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.

Manufacturer & labeler

LabelerSOLA Pharmaceuticals, LLC
Application holderSOLUBIOMIX LLC
FDA applicationNDA217927 (NDA)
Labeler code70512
First marketedDec 2025
Product typeHuman Prescription Drug
Portfolio24 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

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

Warning: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS . 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) COXANTO 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) 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) ]. OXAPROZIN is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications (4) and Warnings and Precautions (5.1) ] . Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [ see Warnings and Precautions (5.2) ].

🎯 Indications and Usage 76 words ▾

1 INDICATIONS AND USAGE OXAPROZIN is indicated: For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis For relief of the signs and symptoms of juvenile rheumatoid arthritis OXAPROZIN CAPSULES is a non-steroidal anti-inflammatory drug indicated for: Relief of signs and symptoms of Osteoarthritis (OA) (1) Relief of signs and symptoms of Rheumatoid Arthritis (RA) (1) Relief of signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) (1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2.1) OA: 1200 mg (four 300 mg caplets) given orally once a day ( 2.2, 2.5, 14.1) RA: 1200 mg (four 300 mg caplets) given orally once a day ( 2.3, 2.5, 14.2) JRA: 600 mg (two 300 mg capsules) once daily in patients 22 to 31 kg. 900 mg (three 300 mg capsules) once daily in patients 32 to 54 kg. 1,200 mg (four 300 mg capsules) once daily in patients 55 kg or greater ( 2.4, 2.5) Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2.1) OA: 1200 mg (four 300 mg caplets) given orally once a day ( 2.2, 2.5, 14.1) RA: 1200 mg (four 300 mg caplets) given orally once a day ( 2.3, 2.5, 14.2) JRA: 600 mg (two 300 mg capsules) once daily in patients 22 to 31 kg.

900 mg (three 300 mg capsules) once daily in patients 32 to 54 kg. 1,200 mg (four 300 mg capsules) once daily in patients 55 kg or greater ( 2.4, 2.5)

2.1General Dosing Instructions Carefully consider the potential benefits and risks of OXAPROZIN CAPSULES and other treatment options before deciding to use OXAPROZIN CAPSULES. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS (5)]. Different dose strengths and formulations (e.g., capsules, tablets) of oral oxaprozin are not interchangeable.

This difference should be taken into consideration when changing strengths or formulations [see Dosage and Administration (2.2, 2.3, 2.4), Cinical Pharmacology (12.3)]. The highest daily dose for OXAPROZIN CAPSULES is 1,200 mg a day.

2.2Osteoarthritis For OA, the dosage is 1,200 mg (four 300 mg capsules) given orally once a day [see DOSAGE AND ADMINISTRATION (2.5)].

2.3Rheumatoid Arthritis For RA, the dosage is 1,200 mg (four 300 mg capsules) given orally once a day [see DOSAGE AND ADMINISTRATION (2.5)].

2.4Juvenile Rheumatoid Arthritis For JRA, in patients 6 to 16 years of age, the recommended dosage given orally once per day should be based on body weight of the patient as given in Table 1 [see DOSAGE AND ADMINISTRATION (2.5)]. Table 1. Recommended Daily Dose of OXAPROZIN CAPSULES by Body Weight in Pediatric Patients Body Weight Range (kg) Dose (mg) Number of Capsules 22 to 31 kg 600mg Two capsules 32 to 54 kg 900mg Three capsules 2 to 54 kg 1,200mg Four capsules

2.5Individualization of Dosage After observing the response to initial therapy with OXAPROZIN CAPSULES, the dose and frequency should be adjusted to suit an individual patient's needs. In osteoarthritis and rheumatoid arthritis and juvenile rheumatoid arthritis, the dosage should be individualized to the lowest effective dose of OXAPROZIN CAPSULES to minimize adverse effects. The maximum recommended total daily dose of OXAPROZIN CAPSULES in adults and pediatric patients is 1,200 mg.

Patients with low body weight should initiate therapy with 600 mg once daily. Patients with severe renal impairment or on dialysis should also initiate therapy with 600 mg once daily. If there is insufficient relief of symptoms in such patients, the dose may be cautiously increased to 1,200 mg, but only with close monitoring [see CLINICAL PHARMACOLOGY (12.3)].

Physicians should ensure that patients are tolerating lower doses without gastroenterologic, renal, hepatic, or dermatologic adverse effects before advancing to larger doses. Most patients will tolerate once-a-day dosing with OXAPROZIN CAPSULES, although divided doses may be tried in patients unable to tolerate single doses.

💊 Dosage Forms and Strengths 27 words ▾

3 DOSAGE FORMS AND STRENGTHS OXAPROZIN CAPSULES (oxaprozin) capsules: 300 mg capsules, white opaque capsule imprinted “403” on the cap in black ink Capsules: 300 mg (3)

⛔ Contraindications 113 words ▾

4 CONTRAINDICATIONS SECTION OXAPROZIN CAPSULES is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to oxaprozin 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 CABG surgery [see WARNINGS AND PRECAUTIONS (5.1)] Known hypersensitivity to oxaprozin 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 OXAPROZIN CAPSULES 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 OXAPROZIN CAPSULES 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: OXAPROZIN CAPSULES is contraindicated in patients with aspirin-sensitive asthma.

Monitor patients with preexisting asthma (without aspirin sensitivity) (5.8) Serious Skin Reactions: Discontinue OXAPROZIN CAPSULES at first appearance of skin rash or other signs of hypersensitivity (5.9) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically (5.10) Fetal Toxicity: Limit use of NSAIDs, including OXAPROZIN CAPSULES, 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 cyclooxygenase-2 (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 oxaprozin, 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 to 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 Regi… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elswhere in the labeling: Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS (5.1)] GI Bleeding, Ulceration and Perforation [see 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)] Hematologic Toxicity [see WARNINGS AND PRECAUTIONS (5.12)] Most common adverse reactions (incidence > 3%) are: constipation, diarrhea, dyspepsia, nausea, rash (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Solubiomix, LLC at 1-844-551-9911 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. Adverse reaction data were derived from patients who received oxaprozin, the active component of OXAPROZIN CAPSULES, in multidose, controlled, and open-label clinical trials. Rates for events from clinical trial experience are based on 2253 patients who took 1,200 mg to 1800 mg of the active component of OXAPROZIN CAPSULES per day in clinical trials.

Of these, 1721 patients were treated for at least 1 month, 971 patients for at least 3 months, and 366 patients for more than 1 year. Incidence Greater than 1%: In clinical trials of oxaprozin, the active component of OXAPROZIN CAPSULES, or in patients taking other NSAIDs, the following adverse reactions occurred at an incidence greater than 1%. Cardiovascular system: edema.

Digestive system: abdominal pain/distress, anorexia, constipation, diarrhea, dyspepsia, flatulence, gastrointestinal ulcers (gastric/duodenal), gross bleeding/perforation, heartburn, liver enzyme elevations, nausea, vomiting. Hematologic system: anemia, increased bleeding time. Nervous system: CNS inhibition (depression, sedation, somnolence, or confusion), disturbance of sleep, dizziness, headache.

Skin and appendages: pruritus, rash. Special senses: tinnitus. Urogenital system: abnormal renal function, dysuria or frequency.

Incidence Greater than 1%: The following adverse reactions were reported in clinical trials or in patients taking other NSAIDs. Body as a whole: appetite changes, death, drug hypersensitivity reactions including anaphylaxis, fever, infection, sepsis. Cardiovascular system: arrhythmia, blood pressure changes, congestive heart failure, hypertension, hypotension, myocardial infarction, palpitations, tachycardia, syncope, vasculitis.

Digestive system: alteration in taste, dry mouth, eructation, esophagitis, gastritis, glossitis, hematemesis, jaundice, liver function abnormalities including liver failure, stomatitis, hemorrhoidal or rectal bleeding. Hematologic system: aplastic anemia, ecchymoses, eosinophilia, hemolytic anemia, lymphadenopathy, melena, purpura, thrombocytopenia, leukopenia. Metabolic system: hyperglycemia, weight changes.

Nervous system: anxiety, asthenia, coma, convulsions, dream abnormalities, drowsiness, hallucinations, insomnia, malaise, meningitis, nervousness, paresthesia, tremors, vertigo, weakness. Respiratory system: asthma, dyspnea, pulmonary infections, pneumonia, sinusitis, symptoms of upper respiratory tract infection, respiratory depression. Skin: alopecia, angioedema, urticaria, photosensitivity, sweat.

Special senses: blurred vision, conjunctivitis, hearing decrease. Urogenital: cystitis, hematuria, increase in menstrual flow, oliguria/ polyuria, proteinuria, renal insufficiency, decreased menstrual flow. Adverse Reactions in Pediatric Patients with Juvenile Rheumatoid Arthritis… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS See TABLE 2 for clinically significant drug interactions with oxaprozin [see CLINICAL PHARMACOLOGY (12.3)]. Table 2: Clinically Significant Drug Interactions with Oxaprozin Drugs That Interfere with Hemostasis Clinical Impact: Oxaprozin and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of oxaprozin 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 OXAPROZIN CAPSULES with anticoagulants (e.g., warfarin), antiplatelet drugs (e.g., aspirin), SSRIs, and 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 OXAPROZIN CAPSULES and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see WARNINGS AND PRECAUTIONS (5.12) ].

OXAPROZIN CAPSULES is not a substitute for low dose aspirin for cardiovascular protection. ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of ACE inhibitors, ARBs, or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure.

These effects are usually reversible. Intervention: During concomitant use of OXAPROZIN CAPSULES and ACE inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. During concomitant use of OXAPROZIN CAPSULES 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. Intervention: During concomitant use of OXAPROZIN CAPSULES 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) ]. Digoxin Clinical Impact: The concomitant use of oxaprozin with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.

Intervention: During concomitant use of OXAPROZIN CAPSULES and digoxin, monitor serum digoxin levels. Lithium Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%.

This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis. Intervention: During concomitant use of OXAPROZIN CAPSULES and lithium, monitor patients for si… [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 OXAPROZIN CAPSULES in women who have difficulties conceiving (8.3) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 8/2024

8.1Pregnancy Risk Summary Use of NSAIDs, including OXAPROZIN CAPSULES, 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 OXAPROZIN CAPSULES use between about 20 and 30 weeks of gestation, and avoid OXAPROZIN CAPSULES 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 OXAPROZIN CAPSULES, 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 other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies, oral administration of oxaprozin to pregnant rabbits at doses 0.1 times the maximum daily human dose (based on body surface area) resulted in evidence of teratogenicity; however, oral administration of oxaprozin to pregnant mice and rats during organogenesis at doses 0.2 times and 1.6 times the maximum recommended human dose, respectively, revealed no evidence of teratogenicity or embryotoxicity.

In rat reproduction studies in which oxaprozin was administered through late gestation failure to deliver and a reduction in live birth index was observed at a dose 1.6 times the maximum recommended human dose (based on body surface area). 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 oxaprozin, 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 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 OXAPROZIN CAPSULES, 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 OXAPROZIN CAPSULES treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue OXAPROZIN CAPSULES and follow up according to clinical practice (see DATA).

Labor or Delivery There are no studies on the effects of OXAPROZIN CAPSULES during labor or delivery. In animal studies, NSAIDS, including oxaprozin, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Human Data Premature Closure of Fetal Ductus Arteriosus: Publ… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 148 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 grams to 100 grams in adults, 1 gram 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. For additional information about overdosage treatment contact a poison control center (1-800-222-1222).

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY .

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

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

12.3Pharmacokinetics General Pharmacokinetic Characteristics In dose proportionality studies utilizing 600 mg, 1,200 mg, and 1,800 mg doses, the pharmacokinetics of oxaprozin in healthy subjects demonstrated nonlinear kinetics of both the total and unbound drug in opposite directions, i.e., dose exposure related increase in the clearance of total drug and decrease in the clearance of the unbound drug. Decreased clearance of the unbound drug was related predominantly to a decrease in the volume of distribution of the unbound drug and not an increase inthe elimination half-life.

This phenomenon is considered to have minimal impact on drug accumulation upon multiple dosing. The pharmacokinetic parameters of oxaprozin in healthy subjects receiving a single dose of 600 mg (two 300 mg capsules) are presented in Table 3. Absorption OXAPROZIN CAPSULES is 95% absorbed after oral administration.

Food may reduce the rate of absorption of oxaprozin, but the extent of absorption is unchanged. Distribution The apparent volume of distribution (Vd/F) of total oxaprozin is approximately 11 to 17 L/70 kg. Oxaprozin is 99% bound to plasma proteins, primarily to albumin.

At therapeutic drug concentrations, the plasma protein binding of oxaprozin is saturable, resulting in a higher proportion of the free drug as the total drug concentration is increased. With increases in single doses or following multiple once-daily dosing, the apparent volume of distribution and clearance of total drug increased, while that of unbound drug decreased due to the effects of nonlinear protein binding. Oxaprozin penetrates into synovial tissues of rheumatoid arthritis patients with oxaprozin concentrations 2-fold and 3-fold greater than in plasma and synovial fluid, respectively.

Oxaprozin is expected to be excreted in human milk based on its physical-chemical properties; however, the amount of oxaprozin excreted in breast milk has not been evaluated. Elimination Metabolism Several oxaprozin metabolites have been identified in human urine or feces. Oxaprozin is primarily metabolized in the liver, by both microsomal oxidation (65%) and glucuronic acid conjugation (35%).

Ester and ether glucuronide are the major conjugated metabolites of oxaprozin. On chronic dosing, metabolites do not accumulate in the plasma of patients with normal renal function. Concentrations of the metabolites in plasma are very low.

Oxaprozin's metabolites do not have significant pharmacologic activity. The major ester and ether glucuronide conjugated metabolites have been evaluated along with oxaprozin in receptor binding studies and in vivo animal models and have demonstrated no activity. A small amount (<5%) of active phenolic metabolites are produced, but the contribution to overall activity is limited.

Excretion Approximately 5% of the oxaprozin dose is excreted unchanged in the urine. Sixty-five percent (65%) of the dose is excreted in the urine and 35% in the feces as metabolites. Biliary excretion of unchanged oxaprozin is a minor pathway, and enterohepatic recycling of oxaprozin is insignificant.

Upon chronic dosing, the accumulation half-life is approximately 22 hours. The elimination half-life is approximately twice the accumulation half-life due to inc… [Excerpted — this section continues on DailyMed.]

📋 Description 129 words ▾

11 DESCRIPTION OXAPROZIN CAPSULES (oxaprozin) is a nonsteroidal anti-inflammatory drug, available as capsules of 300 mg for oral administration. The chemical name is 4,5-diphenyl-2-oxazole-propionic acid. The molecular weight is 293.32 g/mol.

Its molecular formula is C18H15NO3, and it has the following chemical structure. Oxaprozin is a white to off-white powder with a slight odor and a melting point of 162°C to 163°C. It is slightly soluble in alcohol and insoluble in water, with an octanol/water partition coefficient of 4.8 at physiologic pH (7.4).

The pKa in water is 4.3. The inactive ingredients in OXAPROZIN CAPSULES include: microcrystalline cellulose, pregelatinized corn starch, hypromellose 2910, sodium starch glycolate, stearic acid, and silicon dioxide. OXAPROZIN CAPSULES 300 mg capsules are white opaque capsules imprinted “403” on the cap in black ink.

CS

💬 Medication Guide ~3 min read ▾

Medication Guide OXAPROZIN CAPSULES OXAPROZIN CAPSULES is a prescription mediciine that contains oxaprozin (a non-steroidal anti-inflammatory drug [NSADI]) What is the most important information I should know about OXAPROZIN CAPSULES and medicines called nonsteroidal anti-inflammatory drugs (NSAIDs)? OXAPROZIN CAPSULES 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 OXAPROZIN CAPSULES right before or after a heart surgery called a "coronary artery bypass graft (CABG)".

Avoid taking OXAPROZIN CAPSULES 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 OXAPROZIN CAPSULES 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: history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called "corticosteroids", "antiplatelet drugs", "anticoagulants", "selective serotonin reuptak inhibitors (SSRIs)", "serotonin norepinephrine reuptake inhibitors (SNRIs)" increasing doses of NSAIDs longer use of NSAIDs smoking drinking alcohol older age poor health advanced liver disease bleeding problems OXAPROZIN CAPSULES should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What is OXAPROZIN CAPSULES?

OXAPROZIN CAPSULES is a prescription medicine used: for relief of the signs and symptoms of osteoarthritis for relief of the signs and symptoms of rheumatoid arthritis for relief of the signs and symptoms of juvenile rheumatoid arthritis. It is not known if OXAPROZIN CAPSULES is safe and effective in children below 6 years of age. Do not take OXAPROZIN CAPSULES: if you are allergic to oxaprozin or to any of the ingredients in OXAPROZIN CAPSULES.

See the end of this Medication Guide for a complete list of ingredients in OXAPROZIN CAPSULES. if you have had an asthma attack, hives, or other allergic reaction after taking aspirin or any other NSAIDs. Severe allergic reactions that have sometimes led to death have happened in people with a history of allergic reactions to NSAIDs. right before or after heart bypass surgery. Before taking OXAPROZIN CAPSULES, tell your healthcare provider about all of your or your child's medical conditions, including if you: have heart problems have bleeding problems have or have had ulcers have liver or kidney problems have high blood pressure have asthma • are pregnant or plan to become pregnant.

Taking OXAPROZIN CAPSULES at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take OXAPROZIN CAPSULES 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 OXAPROZIN CAPSULES after about 30 weeks of pregnancy.

OXAPROZIN CAPSULES may cause fertility problems in females, which may affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you. are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby during treatment with OXAPROZIN CAPSULES.

Tell your healthcare provider about all of the medicines you or your child take, including prescription or over-the-counter medicines, vitamins or herbal supplements. OXAPROZIN CAPSULES 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.

How should I take OXAPROZIN CAPSULES? Take OXAPROZIN CAPSULES exactly a… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES .

14.1Osteoarthritis Oxaprozin, the active component of OXAPROZIN CAPSULES, was evaluated for the management of the signs and symptoms of osteoarthritis in a total of 616 patients in active controlled clinical trials against aspirin (N=464), piroxicam (N=102), and other NSAIDs. The active component of OXAPROZIN CAPSULES was given both in variable (600 to 1,200 mg/day) and in fixed (1,200 mg/day) dosing schedules in either single or divided doses. In these trials, oxaprozin was found to be comparable to 2,600 to 3,200 mg/day doses of aspirin or 20 mg/day doses of piroxicam.

Oxaprozin was effective both in once daily and in divided dosing schedules. In controlled clinical trials several days of oxaprozin therapy were needed for the drug to reach its full effects [see DOSAGE AND ADMINISTRATION (2.5)].

14.2Rheumatoid Arthritis Oxaprozin, the active component of OXAPROZIN CAPSULES, was evaluated for managing the signs and symptoms of rheumatoid arthritis in placebo and active controlled clinical trials in a total of 646 patients. Oxaprozin was given in single or divided daily doses of 600 to 1,800 mg/day and was found to be comparable to 2,600 to 3,900 mg/day of aspirin. At these doses there was a trend (over all trials) for oxaprozin to be more effective and cause fewer gastrointestinal side effects than aspirin.

Oxaprozin was given as a once-a-day dose of 1,200 mg in most of the clinical trials, but larger doses (up to 26 mg/kg or 1,800 mg/day) were used in selected patients. In some patients, OXAPROZIN CAPSULES may be better tolerated in divided doses. Due to its long half-life, several days of oxaprozin were needed for the drug to reach its full effect [see DOSAGE AND ADMINISTRATION (2.5)].

14.3Juvenile Rheumatoid Arthritis In a 3-month open label study, 10 to 20 mg/kg/day of oxaprozin, the active component of OXAPROZIN CAPSULES, were administered to 59 JRA patients. Fifty-two patients completed 3 months of treatment with a mean daily dose of 20 mg/kg [SEE CLINICAL PHARMACOLOGY (12.3)].

🧪 Nonclinical Toxicology 217 words ▾

13 NONCLINICAL TOXICOLOGY .

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In carcinogenicity studies in rats and mice, oxaprozin administration for 2 years was associated with the exacerbation of liver neoplasms (hepatic adenomas and carcinomas) in male CD mice, but not in female CD mice or male or female rats treated with up to 216 mg/kg via the diet (1.7 times the maximum daily human dose of 1,200 mg based on body surface area). The significance of this species- specific finding to man is unknown. Mutagenesis Oxaprozin was not genotoxic in the Ames test, forward mutation in yeast and Chinese hamster ovary (CHO) cells, DNA repair testing in CHO cells, micronucleus testing in mouse bone marrow, chromosomal aberration testing in human lymphocytes, or cell transformation testing in mouse fibroblast.

Impairment of Fertility Oxaprozin administration was not associated with impairment of fertility in male and female rats at oral doses up to 200 mg/kg/day (1.6 times the maximum recommended human daily dose [MRHD] of 1,200 mg based on a body surface area comparison). However, testicular degeneration was observed in beagle dogs treated with 37.5 mg/kg/day (1.0 times the MRHD based on body surface area) of oxaprozin for 42 days or 6 months, a finding not confirmed in other species. The clinical relevance of this finding is not known.

📄 Package Label / Principal Display Panel 28 words ▾

PRINCIPAL DISPLAY PANEL - 300 MG CAPSULE BOTTLE LABEL: ALWAYS DISPENSE WITH MEDICATION GUIDE NDC 70512-787-60 Sola Pharmaceuticals, LLC Oxaprozin Capsules 300 mg 60 Capsules Rx only Oxa

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 Oxaprozin — the program that covers self-administered drugs. 2 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 Oxaprozin. 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
$263.1K
Claims incl. refills
3.2K
Beneficiaries
2.2K
Spend / beneficiary
$118.40
Spend / claim
$83.18
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 Oxaprozin — the ingredient across all brands.

Top reported reactions

Chronic Kidney Disease82
Pain68
Drug Hypersensitivity61
Nausea60
Renal Failure54
Acute Kidney Injury51
Arthralgia50

Age at onset

Adult64
Elderly32

Reporter sex

883 reports
Male · 30%
Female · 69%
Unknown · 0%

Serious outcomes

Hospitalization227
Disabling31
Death31
Life-threatening13
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 82 4
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.

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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by SOLA Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SOLA Pharmaceuticals, 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.
← 70512-0784-60 · SOLA 70512-0790-03 · SOLA →
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.