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Naproxen 500 mg Tablet, 100-count — NDC 49483-0618-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Naproxen 500 mg Tablet, 100-count — NDC 49483-618-01 (Billing 49483-0618-01)

by TIME CAP LABORATORIES · 100 TABLET in 1 BOTTLE, PLASTIC

This is a package of 100 tablets of Naproxen 500 mg Tablet from TIME CAP LABORATORIES, marketed since Jul 2016 and currently FDA-listed; retail pharmacies pay about $0.0565 per tablet (NADAC).

NDC 49483-0618-01
🏷️ FDA NDC (as labeled) 49483-618-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0565 NADAC Per package$5.65 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.2442/unit · Part D plans $0.1110/unit — full pricing hub ↓
Product page 49483-0618-50 Also comes in: 500 tablets 49483-618-50
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Naproxen (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 20, 2026 — Chemical contamination; presence of lead and lithium above specification (Acella Pharmaceuticals, LLC) · FDA recall D-0523-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49483-618-01
Product NDC 49483-618
11-digit billing NDC 49483061801
NCPDP billing unit EA — each (per item)
RxCUI 198012, 198013, 198014
UNII 57Y76R9ATQ
UPC 0349483617016, 0349483618013, 0349483619010
Application # ANDA091416
SPL Set ID 4350a2d9-5228-460e-b7b1-27e8fa846787
Established class (EPC) Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-07-06
Route ORAL
Dosage form TABLET
Substance NAPROXEN
TE code (Orange Book) AB · RLD · RS

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

GPI-14 66100060000315
GPI class Naproxen
GCN Seq No 008362
GCN 35793
HICL code 003727
Ingredient (HICL) Naproxen
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 NAPROXEN 500 MG TABLET
FDB brand name Naproxen
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 008362
  • GCN: 35793
  • GPI-14 (Medi-Span): 66100060000315
  • HICL (First Databank): 003727
  • AHFS class code: 28:08.04.04
  • RxCUI (RxNorm): 198012
Why two NDCs? The FDA registers this code as 49483-618-01 — 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 → 49483-0618-01. 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, Antiinflammatory products for vaginal administration, Antiinflammatory preparations, non-steroids for topical use
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 NAPROXEN 500 MG TABLET Ingredient Naproxen
📖 What it is MedlinePlus · NLM

Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine). Prescription naproxen tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of th...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It relieves pain, inflammation and fever. Prescription versions treat arthritis, tendonitis, bursitis, acute gout and painful periods. Over-the-counter versions handle minor aches...
  • Take it by mouth with a full glass of water. Over-the-counter products are taken every 8 to 12 hours while symptoms last, and you should use the smallest dose that works. For presc...
  • Headache, indigestion, heartburn, nausea and swelling are common. Call your doctor if you have black stools, vomit blood, a rash, yellow skin or eyes, or chest pain.
  • Usually not. Combining naproxen with other NSAIDs or aspirin raises bleeding risk with little added benefit. Naproxen can also interfere with low-dose aspirin taken for your heart,...
📖 Read our full Naproxen guide →
1
Nutrient depletion considerations

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

🧪 Full Naproxen 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 eaPer package
Retail pharmacies payNADAC · weekly $0.057 $5.65 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2442 $24.42 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.1110 $11.10 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.078 $0.057
▼ Down 27% over the last 24 months.
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 Per unit Per pack Marketing startMarketing endStatus
49483-0618-01 You're viewing this 100 TABLET in 1 BOTTLE, PLASTIC $0.0565 / ea $5.65 2016-07-06 — Active
49483-0618-50 49483-618-50 Main listing 500 TABLET in 1 BOTTLE, PLASTIC $0.0565 / ea $28.27 2016-07-06 — Active

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

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0565 NADAC).

This pack accounts for about 44% of this product's recent Medicaid fills; most go to the 500 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle, plastic.
How does this package differ from NDC 49483-0618-50?
Both are Naproxen 500 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 49483-0618-50 is the 500 tablets package.
What NDC number is used to bill for this package of Naproxen 500 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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Naproxen 500 mgthis 49483-0618-01 TIME 100 tablets $0.057 AB Availability likely —
Naproxen 500 mg 50228-0436-01 ScieGen 100 tablets $0.057 AB Availability likely —
Naproxen 500 mg 60687-0491-01 American 100 tablets $0.057 AB Availability likely —
Naproxen 500 mg 65162-0190-10 Amneal 100 tablets $0.057 AB Availability likely —
Naproxen 500 mg 65862-0522-01 Aurobindo 100 tablets $0.057 — Availability likely —
Naproxen 500 mg 68462-0190-01 Glenmark 100 tablets $0.057 AB Availability likely —
Naproxen 500 mg 70010-0139-01 Granules 100 tablets $0.057 AB Availability likely —
Naproxen 500 mg 76282-0342-01 Exelan 100 tablets $0.057 — Availability likely —
Naproxen 500 mg 42494-0454-10 Cameron 100 tablets $1.841 AB Availability likely +3157%
Naproxen 500 mg 00615-8094-39 NCS 30 tablets — AB FDA listed —
Naproxen 500 mg 25000-0140-03 MARKSANS 30 tablets — AB FDA listed —
Naproxen 500 mg 42708-0043-20 QPharma, 20 tablets — AB FDA listed —
Naproxen 500 mg 42708-0140-20 QPharma 20 tablets — AB FDA listed —
Naproxen 500 mg 43063-0920-04 PD-Rx 4 tablets — AB FDA listed —
Naproxen 500 mg 43353-0211-53 Aphena 60 tablets — — FDA listed —
Naproxen 500 mg 50090-0481-00 A-S 15 tablets — AB FDA listed —
Naproxen 500 mg 50090-0482-01 A-S 90 tablets — AB FDA listed —
Naproxen 500 mg 50090-0483-00 A-S 20 tablets — AB FDA listed —
Naproxen 500 mg 50090-5645-00 A-S 15 tablets — AB FDA listed —
Naproxen 500 mg 50090-5646-01 A-S 90 tablets — AB FDA listed —
Naproxen 500 mg 50090-5649-00 A-S 20 tablets — AB FDA listed —
Naproxen 500 mg 50090-6666-00 A-S 15 tablets — AB FDA listed —
Naproxen 500 mg 50090-6667-01 A-S 90 tablets — AB FDA listed —
Naproxen 500 mg 50090-6762-00 A-S 20 tablets — AB FDA listed —
Naproxen 500 mg 50090-6980-00 A-S 90 tablets — AB FDA listed —
Naproxen 500 mg 50090-7198-00 A-S 90 tablets — AB FDA listed —
Naproxen 500 mg 50090-7676-00 A-S 90 tablets — AB FDA listed —
Naproxen 500 mg 51655-0363-26 Northwind 90 tablets — AB FDA listed —
Naproxen 500 mg 51655-0457-20 Northwind 20 tablets — AB FDA listed —
Naproxen 500 mg 51655-0621-20 Northwind 20 tablets — AB FDA listed —
Naproxen 500 mg 51655-0743-20 Northwind 20 tablets — AB FDA listed —
Naproxen 500 mg 53746-0190-01 Amneal 100 tablets — AB FDA listed —
Naproxen 500 mg 55700-0888-20 Quality 20 tablets — AB Discontinued —
Naproxen 500 mg 60760-0564-14 St. 14 tablets — AB FDA listed —
Naproxen 500 mg 62207-0747-43 Granules 100 tablets — AB FDA listed —
Naproxen 500 mg 63187-0028-10 Proficient 10 tablets — AB FDA listed —
Naproxen 500 mg 63187-0455-20 Proficient 20 tablets — AB FDA listed —
Naproxen 500 mg 63629-5863-01 Bryant 60 tablets — AB FDA listed —
Naproxen 500 mg 63629-8514-01 Bryant 500 tablets — AB FDA listed —
Naproxen 500 mg 63629-8515-01 Bryant 100 tablets — AB FDA listed —
Naproxen 500 mg 66267-0153-10 NuCare 10 tablets — AB FDA listed —
Naproxen 500 mg 66267-0807-04 NuCare 4 tablets — AB FDA listed —
Naproxen 500 mg 67046-0501-03 Coupler 30 tablets — AB FDA listed —
Naproxen 500 mg 67046-1553-03 Coupler 30 tablets — AB FDA listed —
Naproxen 500 mg 67296-2235-05 Redpharm 30 tablets — AB FDA listed —
Naproxen 500 mg 68071-2396-04 NuCare 4 tablets — AB FDA listed —
Naproxen 500 mg 68071-4006-01 NuCare 10 tablets — AB FDA listed —
Naproxen 500 mg 68071-4381-02 NuCare 20 tablets — AB FDA listed —
Naproxen 500 mg 68788-7090-01 Preferred 100 tablets — AB FDA listed —
Naproxen 500 mg 68788-8602-01 Preferred 100 tablets — AB FDA listed —
Naproxen 500 mg 68788-8797-01 Preferred 100 tablets — AB FDA listed —
naproxen 500 mg 69097-0855-07 Cipla 100 tablets — — FDA listed —
Naproxen 500 mg 70518-3822-00 REMEDYREPACK 30 tablets — AB FDA listed —
Naproxen 500 mg 70518-4439-00 REMEDYREPACK 12 tablets — AB FDA listed —
Naproxen 500 mg 71205-0597-10 Proficient 10 tablets — AB FDA listed —
Naproxen 500 mg 71335-0345-00 Bryant 28 tablets — AB FDA listed —
Naproxen 500 mg 71335-2485-00 Bryant 28 tablets — AB FDA listed —
Naproxen 500 mg 71335-2777-00 Bryant 28 tablets — AB FDA listed —
Naproxen 500 mg 71610-0436-53 Aphena 60 tablets — AB FDA listed —
Naproxen 500 mg 71610-0489-53 Aphena 60 tablets — AB FDA listed —
Naproxen 500 mg 71610-0597-53 Aphena 60 tablets — AB FDA listed —
Naproxen 500 mg 72189-0136-14 DIRECT 14 tablets — AB FDA listed —
Naproxen 500 mg 72789-0321-04 PD-Rx 4 tablets — AB FDA listed —
Naproxen 500 mg 72789-0541-14 PD-Rx 14 tablets — AB FDA listed —
Naproxen 500 mg 76420-0042-01 Asclemed 1 tablet — AB FDA listed —
Naproxen 500 mg 76420-0264-01 Asclemed 1 tablet — AB FDA listed —
Naproxen 500 mg 77771-0436-01 Radha 100 tablets — AB FDA listed —
Naproxen 500 mg 80425-0049-01 Advanced 60 tablets — AB FDA listed —
Naproxen 500 mg 80425-0050-01 Advanced 60 tablets — AB FDA listed —
Naproxen 500 mg 80425-0051-01 Advanced 60 tablets — AB FDA listed —
Naproxen 500 mg 80425-0378-01 Advanced 30 tablets — AB FDA listed —
Naproxen 500 mg 82461-0711-60 Medcore 60 tablets — AB FDA listed —
Naproxen 500 mg 83209-0190-14 Boswell 14 tablets — AB FDA listed —
Naproxen 500 mg 85509-1436-03 PHOENIX 30 tablets — AB FDA listed —
Naproxen 500 mg 85766-0107-00 Sportpharm 1000 tablets — AB FDA listed —
Naproxen 500 mg 72162-2276-01 Bryant 100 tablets — AB FDA listed —
Naproxen 500 mg 87441-0060-01 Unit 30 tablets — AB Discontinued —
Naproxen 500 mg 85534-0024-00 HAWAII 30 tablets — AB FDA listed —
Naproxen 500 mg 70518-1516-00 REMEDYREPACK 30 tablets — AB Discontinued —
Naproxen 500 mg 67046-0784-03 Coupler 30 tablets — AB FDA listed —
Naproxen 500 mg 70518-4750-00 REMEDYREPACK 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2016
On the market since
Jul 2016
📍
2026
Currently FDA-listed
10 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 white
ShapeRound
Imprint138
Size1 mm
ScoringScored — splits in 2
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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.

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

LabelerTIME CAP LABORATORIES
Application holderADAPTIS PHARMA PRIVATE LTD
FDA applicationANDA091416 (ANDA)
Labeler code49483
First marketedJul 2016
Product typeHuman Prescription Drug
Portfolio3 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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 How Supplied / Storage and Handling 💬 Medication Guide 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 132 words ▾

CAREFULLY CONSIDER THE POTENTIAL BENEFITS AND RISKS OF NAPROXEN AND OTHER TREATMENT OPTIONS BEFORE DECIDING TO USE NAPROXEN TABLETS. USE THE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH INDIVIDUAL PATIENT TREATMENT GOALS (SEE WARNINGS: GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). NAPROXEN TABLETS ARE INDICATED: FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS.

FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF ANKYLOSING SPONDYLITIS FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF JUVENILE ARTHRITIS NAPROXEN TABLETS ARE ALSO INDICATED: FOR RELIEF OF THE SIGNS AND SYMPTOMS OF TENDONITIS FOR RELIEF OF THE SIGNS AND SYMPTOMS OF BURSITIS FOR RELIEF OF THE SIGNS AND SYMPTOMS OF ACUTE GOUT FOR THE MANAGEMENT OF PAIN FOR THE MANAGEMENT OF PRIMARY DYSMENORRHEA

⏱️ Dosage and Administration ~3 min read ▾

CAREFULLY CONSIDER THE POTENTIAL BENEFITS AND RISKS OF NAPROXEN AND OTHER TREATMENT OPTIONS BEFORE DECIDING TO USE NAPROXEN TABLETS. USE THE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH INDIVIDUAL PATIENT TREATMENT GOALS (SEE WARNINGS; GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). AFTER OBSERVING THE RESPONSE TO INITIAL THERAPY WITH NAPROXEN TABLETS, THE DOSE AND FREQUENCY SHOULD BE ADJUSTED TO SUIT AN INDIVIDUAL PATIENT'S NEEDS.

DIFFERENT DOSE STRENGTHS AND FORMULATIONS (I.E., TABLETS, SUSPENSION) OF THE DRUG ARE NOT NECESSARILY BIOEQUIVALENT. THIS DIFFERENCE SHOULD BE TAKEN INTO CONSIDERATION WHEN CHANGING FORMULATION. ALTHOUGH NAPROXEN TABLETS, NAPROXEN SUSPENSION, NAPROXEN DELAYED-RELEASED TABLETS, AND NAPROXEN SODIUM TABLETS ALL CIRCULATE IN THE PLASMA AS NAPROXEN, THEY HAVE PHARMACOKINETIC DIFFERENCES THAT MAY AFFECT ONSET OF ACTION.

ONSET OF PAIN RELIEF CAN BEGIN WITHIN 1 HOUR IN PATIENTS TAKING NAPROXEN. THE RECOMMENDED STRATEGY FOR INITIATING THERAPY IS TO CHOOSE A FORMULATION AND A STARTING DOSE LIKELY TO BE EFFECTIVE FOR THE PATIENT AND THEN ADJUST THE DOSAGE BASED ON OBSERVATION OF BENEFIT AND/OR ADVERSE EVENTS. A LOWER DOSE SHOULD BE CONSIDERED IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT OR IN ELDERLY PATIENTS (SEE WARNINGS; HEPATOTOXICITY, AND RENAL TOXICITY AND HYPERKALEMIA, AND PRECAUTIONS; GERIATRIC USE).

GERIATRIC PATIENTS STUDIES INDICATE THAT ALTHOUGH TOTAL PLASMA CONCENTRATION OF NAPROXEN IS UNCHANGED, THE UNBOUND PLASMA FRACTION OF NAPROXEN IS INCREASED IN THE ELDERLY. CAUTION IS ADVISED WHEN HIGH DOSES ARE REQUIRED AND SOME ADJUSTMENT OF DOSAGE MAY BE REQUIRED IN ELDERLY PATIENTS. AS WITH OTHER DRUGS USED IN THE ELDERLY, IT IS PRUDENT TO USE THE LOWEST EFFECTIVE DOSE.

PATIENTS WITH MODERATE TO SEVERE RENAL IMPAIRMENT NAPROXEN-CONTAINING PRODUCTS ARE NOT RECOMMENDED FOR USE IN PATIENTS WITH MODERATE TO SEVERE AND SEVERE RENAL IMPAIRMENT (CREATININE CLEARANCE < 30 ML/MIN) (SEE WARNINGS: RENAL EFFECTS). RHEUMATOID ARTHRITIS, OSTEOARTHRITIS AND ANKYLOSING SPONDYLITIS THE RECOMMENDED DOSE IS 250 MG, 375 MG, OR 500 MG TWICE DAILY. DURING LONG-TERM ADMINISTRATION, THE DOSE OF NAPROXEN MAY BE ADJUSTED UP OR DOWN DEPENDING ON THE CLINICAL RESPONSE OF THE PATIENT.

A LOWER DAILY DOSE MAY SUFFICE FOR LONG-TERM ADMINISTRATION. THE MORNING AND EVENING DOSES DO NOT HAVE TO BE EQUAL IN SIZE AND THE ADMINISTRATION OF THE DRUG MORE FREQUENTLY THAN TWICE DAILY IS NOT NECESSARY. IN PATIENTS WHO TOLERATE LOWER DOSES WELL, THE DOSE MAY BE INCREASED TO NAPROXEN 1500 MG/DAY FOR LIMITED PERIODS OF UP TO 6 MONTHS WHEN A HIGHER LEVEL OF ANTI-INFLAMMATORY/ANALGESIC ACTIVITY IS REQUIRED.

WHEN TREATING SUCH PATIENTS WITH NAPROXEN 1500 MG/DAY, THE PHYSICIAN SHOULD OBSERVE SUFFICIENT INCREASED CLINICAL BENEFITS TO OFFSET THE POTENTIAL INCREASED RISK. THE MORNING AND EVENING DOSES DO NOT HAVE TO BE EQUAL IN SIZE AND ADMINISTRATION OF THE DRUG MORE FREQUENTLY THAN TWICE DAILY DOES NOT GENERALLY MAKE A DIFFERENCE IN RESPONSE (SEE CLINICAL PHARMACOLOGY). JUVENILE ARTHRITIS NAPROXEN TABLETS MAY NOT ALLOW FOR THE FLEXIBLE DOSE TITRATION NEEDED IN PEDIATRIC PATIENTS WITH JUVENILE ARTHRITIS.

A LIQUID FORMULATION MAY BE MORE APPROPRIATE. IN PEDIATRIC PATIENTS, DOSES OF 5 MG/KG/DAY PRODUCED PLASMA LEVELS OF NAPROXEN SIMILAR TO THOSE SEEN IN ADULTS TAKING 500 MG OF NAPROXEN (SEE CLINICAL PHARMACOLOGY). THE RECOMMENDED TOTAL DAILY DOSE OF NAPROXEN IS APPROXIMATELY 10 MG/KG GIVEN IN 2 DIVIDED DOSES.

ONE-HALF OF THE 250 MG TABLET WILL BE NEEDED FOR DOSING LOWER-WEIGHT CHILDREN. DOSING WITH NAPROXEN TABLETS IS NOT APPROPRIATE FOR CHILDREN WEIGHING LESS THAN 25 KILOGRAMS. THE RECOMMENDED TOTAL DAILY DOSE OF NAPROXEN IS APPROXIMATELY 10 MG/KG GIVEN IN 2 DIVIDED DOSES (I.E., 5 MG/KG GIVEN TWICE A DAY).

NAPROXEN TABLETS ARE NOT WELL SUITED TO THIS DOSAGE SO USE OF NAPROXEN ORAL SUSPENSION IS RECOMMENDED FOR THIS INDICATION. MANAGEMENT OF PAIN, PRIMARY DYSMENORRHEA, AND ACUTE TENDONITIS AND BURSITIS BECAUSE THE SODIUM SALT O… [Excerpted — this section continues on DailyMed.]

⚠️ Warnings ~3 min read ▾

CARDIOVAS CULAR THROMBOTIC EVENTS CLINICAL TRIALS OF SEVERAL COX-2 SELECTIVE AND NON-SELECTIVE NSAIDS OF UP TO THREE YEARS DURATION HAVE SHOWN AN INCREASED RISK OF SERIOUS CARDIOVASCULAR (CV) THROMBOTIC EVENTS, MYOCARDIAL INFARCTION, AND STROKE, WHICH CAN BE FATAL. 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. SOMEOBSERVATIONAL 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 NAPROXEN, INCREASES THE RISK OF SERIOUS GASTROINTESTINAL (GI) EVENTS (SEE WARNINGS; GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). 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). POST-MI PATIENTS OBSERVATIONAL STUDIES CONDUCTED IN THE DANISH NATIONAL REGISTRY HAVE DEMONSTRATED THAT PATIENTS TREATED WITH NSAIDS IN THE POST-MI PERIOD WERE AT INCREASED RISK OF REINFARCTION, CV-RELATED DEATH, AND ALL CAUSE MORTALITY BEGINNING IN THE FIRST WEEK OF TREATMENT. IN THIS SAME COHORT, THE INCIDENCE OF DEATH IN THE FIRST YEAR POST-MI WAS 20 PER 100 PERSON YEARS IN NSAID-TREATED PATIENTS COMPARED TO 12 PER 100 PERSON YEARS IN NON-NSAID EXPOSED PATIENTS.

ALTHOUGH THE ABSOLUTE RATE OF DEATH DECLINED SOMEWHAT AFTER THE FIRST YEAR POST-MI, THE INCREASED RELATIVE RISK OF DEATH IN NSAID USERS PERSISTED OVER AT LEAST THE NEXT FOUR YEARS OF FOLLOW-UP. AVOID THE USE OF NAPROXEN IN PATIENTS WITH A RECENT MI UNLESS THE BENEFITS ARE EXPECTED TO OUTWEIGH THE RISK OF RECURRENT CV THROMBOTIC EVENTS. IF NAPROXEN IS USED IN PATIENTS WITH A RECENT MI, MONITOR PATIENTS FOR SIGNS OF CARDIAC ISCHEMIA.

GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION NSAIDS, INCLUDING NAPROXEN CAUSE SERIOUS GASTROINTESTINAL (GI) ADVERSE EVENTS INCLUDING INFLAMMATION, BLEEDING, ULCERATION, AND PERFORATION OF THE ESOPHAGUS, STOMACH, SMALL INTESTINE, OR LARGE INTESTINE, WHICH CAN BE FATAL. THESE SERIOUS ADVERSE EVENTS CAN OCCUR AT ANY TIME, WITH OR WITHOUT WARNING SYMPTOMS, IN PATIENTS TREATED WITH NSAIDS. ONLY ONE IN FIVE PATIENTS WHO DEVELOP A SERIOUS UPPER GI ADVERSE EVENT ON NSAID THERAPY IS SYMPTOMATIC.

UPPER GI ULCERS, GROSS BLEEDING, OR PERFORATION CAUSED BY NSAIDS OCCURRED IN APPROXIMATELY 1% OF PATIENTS TREATED FOR 3-6 MONTHS, AND IN ABOUT 2%- 4% OF PATIENTS TREATED FOR ONE YEAR. HOWEVER, EVEN SHORT-TERM NSAID THERAPY IS NOT WITHOUT RISK. RISK FACTORS FOR GI BLEEDING, ULCERATION, AND PERFORATION PATIENTS WITH A PRIOR HISTORY OF PEPTIC ULCER DISEASE AND/OR GI BLEEDING WHO USED NSAIDS HAD A GREATER THAN 10-FOLD INCREASED RISK FOR DEVELOPING A GI BLEED COMPARED TO PATIENTS WITHOUT THESE RISK FACTORS.

OTHER FACTORS THAT INCREASE THE RISK… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 132 words ▾

NAPROXEN TABLETS 250 MG : WHITE TO OFF-WHITE, ROUND SHAPED TABLET WITH “138” DEBOSSED ON ONE SIDE AND SCORED ON OTHER SIDE. PACKAGED IN LIGHT-RESISTANT BOTTLES OF 100 AND 500. 100'S (BOTTLE): NDC 49483-619-01 500’S (BOTTLE): NDC 49483-619-50 375 MG : WHITE TO OFF-WHITE, OVAL SHAPED TABLET WITH “139” DEBOSSED ON ONE SIDE AND PLAIN ON OTHER SIDE.

PACKAGED IN LIGHT-RESISTANT BOTTLES OF 100 AND 1000. 100'S (BOTTLE): NDC 49483-617-01 500’S (BOTTLE): NDC 49483-617-50 500 MG : WHITE TO OFF-WHITE, CAPSULE-SHAPED TABLETS WITH “140” DEBOSSED ON ONE SIDE AND SCORED ON OTHER SIDE. PACKAGED IN LIGHT-RESISTANT BOTTLES OF 100 AND 500.

100'S (BOTTLE): NDC 49483-618-01 500’S (BOTTLE): NDC 49483-618-50 STORE AT 20°-25°C (68°-77°F) EXCURSIONS PERMITTED TO 15°-30°C (59°-86°F) IN WELL-CLOSED CONTAINERS [SEE USP CONTROLLED ROOM TEMPERATURE]. DISPENSE IN LIGHT-RESISTANT CONTAINERS. RX ONLY

💬 Medication Guide ~3 min read ▾

MED GUIDE FOR NAPROXEN TABLETS USP 250 MG 375 MG 500 MG Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Medication Guide for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Non-Steroidal 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: o with increasing doses of NSAIDs o 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: o any time during use o without warning symptoms o that may cause death The risk of getting an ulcer or bleeding increases with: o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs o taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” o increasing doses of NSAIDs o older age o longer use of NSAIDs o poor health o smoking o advanced liver disease o drinking alcohol o bleeding problems NSAIDs should only be used: o exactly as prescribed o at the lowest dose possible for your treatment o 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. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy. • are breastfeeding or plan to breastfeed.

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

📄 Package Label / Principal Display Panel 30 words ▾

619R - NAPROXEN 250 MG 100 COUNT 250 MG 100 COUNT

617R NAPROXEN 375 MG 100 COUNT 375MG 100 COUNT

618R NAPROXEN 500 MG 100 COUNT 500 MG 100 COUNT

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2.4K
Units reimbursed last 4 qtrs
94.3K
Gross reimbursed last 4 qtrs
$23K
Avg / prescription
$9.72
Avg / unit
$0.2442
Latest quarter Q4 2025
516Rx
Medicaid pays / ea
$0.2442
gross reimbursed
vs
NADAC / ea
$0.0565
acquisition cost
=
Spread
+$0.1877
+332% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
65% FFS 35% MCO
Fee-for-service · 1,547 Rx Managed care · 820 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 58,336 units · 298 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 1,562 units · 48.9 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 3,986 units · 42.9 per 100k residents NJ Massachusetts: no data reported MA California: 9,077 units · 23.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 6,768 units · 110 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: 1,454 units · 214 per 100k residents DC Hawaii: no data reported HI Texas: no data reported TX Florida: 4,668 units · 20.6 per 100k residents FL
Units reimbursed · per 100k residents
20.6298
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 298 /100k
2 D.C. 214 /100k
3 Maryland 110 /100k
4 Nevada 48.9 /100k
5 New Jersey 42.9 /100k
6 California 23.3 /100k
7 Florida 20.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
500 tablets49483-0618-50 2,981 Rx · $30,476
100 tablets this page49483-0618-01 2,367 Rx · $23,019
Drug total (last 4 qtrs): 5,348 Rx · 215,565 units · $53,495 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Naproxen — the program that covers self-administered drugs. 17 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 Naproxen. 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
$5.99M
Claims incl. refills
655K
Beneficiaries
478.5K
Spend / beneficiary
$12.52
Spend / claim
$9.15
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.
← 49483-0617-01 · TIME 49483-0619-01 · TIME →
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.