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Naproxen 500 mg Tablet, 500-count

by Aurobindo Pharma Limited · 500 TABLET in 1 BOTTLE (65862-522-05)

NDC 65862-0522-05

🏷️ FDA NDC (as labeled) 65862-522-05 billing pads the product segment with a zero

This package

Contains500-count Cost per ea$0.0580 NADAC Per package$29.00 / 500 tablets Pack sizes4 compare ↓

Also priced by: Medicaid pays $0.2414/unit · Part D plans $0.1110/unit — full pricing hub ↓

Also comes in: 100 tablets 65862-0522-01 2000 tablets 65862-0522-22 2500 tablets 65862-0522-26

On market Non-controlled

🗂️ Data synced Sep 17, 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 Dr. Brian Staiger, PharmD

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

FDA NDC (as labeled) 65862-522-05

Product NDC 65862-522

11-digit billing NDC 65862052205

NCPDP billing unit EA — each (per item)

SPL Set ID 0e5315bc-c02f-4749-be69-b5b528327d58

DEA schedule Non-controlled

Marketing category DRUG FOR FURTHER PROCESSING

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2011-11-08

Dosage form TABLET

Substance NAPROXEN

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

Why two NDCs? The FDA registers this code as 65862-522-05 — 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 → 65862-0522-05. 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.

🏭 Manufacturer & labeler

LabelerAurobindo Pharma Limited

Labeler code65862

First marketedNov 2011

Product typeDrug For Further Processing

Portfolio1,452 products on file

🔎 All NDCs from Aurobindo Pharma Limited

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name NAPROXEN 500 MG TABLET Ingredient Naproxen

📗 Our plain-language guide HelloPharmacist

They're very similar — naproxen sodium is just the salt form of naproxen, and it dissolves in water more quickly. That means your body absorbs naproxen sodium a bit faster, so it t...
What's the difference between naproxen and naproxen sodium — are they the same thing?
You can take it either way, but taking it with food, milk, or a full glass of water is a good idea because it helps protect your stomach. Naproxen can irritate the lining of your s...
Can I take naproxen on an empty stomach, or do I need to eat first?

📖 Read our full Naproxen guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Naproxen — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Naproxen (311 interactions) — ranked by severity →

Nutrient depletion considerations

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

FOLIC ACID Insufficient Evidence

🧪 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.

💊 What it looks like

Color Yellow

ShapeCapsule

ImprintT;20

Size19 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 EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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.

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

Where does this data come from?

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.058	$29.00 / 500 tablets
Medicaid paysCMS SDUD · 12 mo	$0.2414	$120.70 / 500 tablets
Medicare drug plans payPart D · Q2 2026	$0.1110	$55.50 / 500 tablets

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 21% 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Naproxen 500 mg 49483-0618-01	TIME	100 tablets	$0.058	AB	Availability likely	—
Naproxen 500 mg 50228-0436-01	ScieGen	100 tablets	$0.058	AB	Availability likely	—
Naproxen 500 mg 60687-0491-01	American	100 tablets	$0.058	AB	Availability likely	—
Naproxen 500 mg 65162-0190-10	Amneal	100 tablets	$0.058	AB	Availability likely	—
Naproxen 500 mgthis 65862-0522-05	Aurobindo	500 tablets	$0.058	—	Availability likely	—
Naproxen 500 mg 68462-0190-01	Glenmark	100 tablets	$0.058	AB	Availability likely	—
Naproxen 500 mg 70010-0139-01	Granules	100 tablets	$0.058	AB	Availability likely	—
Naproxen 500 mg 76282-0342-01	Exelan	100 tablets	$0.058	—	Availability likely	—
Naproxen 500 mg 42494-0454-10	Cameron	100 tablets	$1.864	AB	Availability likely	+3115%
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	FDA listed	—
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: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.

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

🏛️

2011

On the market since

Nov 2011

📍

2026

Currently FDA-listed

15 years listed

🔓

Generic versions listed

see equivalents

✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

🗺️ 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 65862-0522-05, 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 – Q1 2026 · 5 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

38.9K

Units reimbursed last 4 qtrs

1.6M

Gross reimbursed last 4 qtrs

$394.5K

Avg / prescription

$10.15

Avg / unit

$0.2414

Latest quarter Q1 2026

14.3KRx

Medicaid pays / ea

$0.2414

gross reimbursed

NADAC / ea

$0.0580

acquisition cost

Spread

+$0.1834

+316% 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 ⓘ

49% FFS 51% MCO

Fee-for-service · 19,069 Rx Managed care · 19,784 Rx

State Medicaid map

Units reimbursed · per 100k residents

9.32,609

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 2,609 /100k

2 New Jersey 1,371 /100k

3 Michigan 1,022 /100k

4 Kentucky 972 /100k

5 Ohio 940 /100k

6 Connecticut 778 /100k

7 Nevada 770 /100k

8 D.C. 731 /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 tablets this page65862-0522-05 38,853 Rx · $394,457

100 tablets65862-0522-01 6,218 Rx · $61,932

2500 tablets65862-0522-26 No Medicaid data

2000 tablets65862-0522-22 No Medicaid data

Drug total (last 4 qtrs): 45,071 Rx · 1,895,511 units · $456,390 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 (matched by generic name) — 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.

🔬 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 Naproxen — the ingredient across all brands.

Top reported reactions

Pain13,409

Fatigue13,047

Nausea12,185

Arthralgia11,086

Headache10,504

Diarrhoea9,841

Dizziness9,098

Age at onset

Neonate147

Infant81

Child444

Adolescent528

Adult19,141

Elderly11,983

Reporter sex

Male · 32%

Female · 67%

Unknown · 0%

Serious outcomes

Hospitalization41,131

Disabling9,239

Life-threatening9,236

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
65862-0522-01	100 TABLET in 1 BOTTLE (65862-522-01)	$0.0580 / ea	$5.80	2011-11-08	Active
65862-0522-05 You're viewing this	500 TABLET in 1 BOTTLE (65862-522-05)	$0.0580 / ea	$29.00	2011-11-08	Active
65862-0522-26	2500 TABLET in 1 BOTTLE (65862-522-26)	—	—	2011-11-08	Active
65862-0522-22	2000 TABLET in 1 BAG (65862-522-22)	—	—	—	Active

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

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0580 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 86% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 65862-0522-05?

NDC 65862-0522-05 is a 500-count package — 500 tablet in 1 bottle.

What is the difference between NDC 65862-0522-05 and NDC 65862-0522-01?

Both are Naproxen 500 mg Tablet — the drug itself is identical. NDC 65862-0522-05 is the 500-count package, while NDC 65862-0522-01 is the 100 tablets package.

What NDC number is used to bill for this package of Naproxen 500 mg Tablet?

Bill NDC 65862-0522-05 — the 11-digit billing format is 65862052205. 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.

🧭 About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Aurobindo Pharma Limited supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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)	✓ Available
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)	✓ Available

“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

Is this NDC FDA-approved?

An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 65862-522-05, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 65862-0522-05, written without dashes as 65862052205. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 65862-0522-05, the first segment (65862) is the labeler code FDA assigned to Aurobindo Pharma Limited; the middle segment (0522) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aurobindo Pharma Limited. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 3 other package presentations of this same product, including 100 tablets (65862-0522-01), 2000 tablets (65862-0522-22), 2500 tablets (65862-0522-26). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Aurobindo Pharma Limited 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.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🚨 Boxed Warning ~1 min read ▾

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

Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2) ].

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.

( 5.1 ) Naproxen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. ( 4 , 5.1 ) NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms.

Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. ( 5.2 )

🎯 Indications and Usage 74 words ▾

1 INDICATIONS AND USAGE Naproxen tablets are indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis tendonitis bursitis acute gout the management of: pain primary dysmenorrhea Naproxen tablets are non-steroidal anti-inflammatory drugs indicated for: ( 1 ) the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis tendonitis bursitis acute gout the management of: pain primary dysmenorrhea

⏱️ 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 ) Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis Naproxen Tablets 250 mg or 375 mg or 500 mg twice daily twice daily twice daily The dose may be adjusted up or down depending on the clinical response of the patient. In patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/day for up to 6 months.

Polyarticular Juvenile Idiopathic Arthritis Naproxen tablets may not allow for the flexible dose titration needed in pediatric patients with polyarticular juvenile idiopathic arthritis. A liquid formulation may be more appropriate. Recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses.

Dosing with naproxen tablets is not appropriate for children weighing less than 50 kilograms. Acute Gout Recommended starting dose 750 mg of naproxen tablets followed by 250 mg every 8 hours until the attack has subsided.

2.1General Dosing Instructions Carefully consider the potential benefits and risks of naproxen tablets 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 and Precautions (5) ]. After observing the response to initial therapy with naproxen tablets the dose and frequency should be adjusted to suit an individual patient’s needs.

Naproxen-containing products such as naproxen tablets and other naproxen products should not be used concomitantly since they all circulate in the plasma as the naproxen anion.

2.2Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis The recommended dosages of naproxen tablets are shown in Table 1. Table 1: Recommended dosages for N aproxen Tablets Naproxen Tablets 250 mg or 375 mg or 500 mg twice daily twice daily 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 administration of the drug more frequently than twice daily does not generally make a difference in response. 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.

2.3Polyarticular Juvenile Idiopathic Arthritis Naproxen solid-oral dosage forms may not allow for the flexible dose titration needed in pediatric patients with polyarticular juvenile idiopathic arthritis. A liquid formulation may be more appropriate for weight-based dosing and due to the need for dose flexibility in children. 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 (12) ] .

The recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses. Dosing with naproxen tablets is not appropriate for children weighing less than 50 kilograms.

2.4Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis The recommended starting dose of naproxen tablets is 500 mg followed by 250 mg every 6 to 8 hours as required. The total daily dose should not exceed 1250 mg of naproxen.

2.5Acute Gout The recommended starting dose is 750 mg of naproxen tablets followed by 250 mg every 8 hours until the attack has subsided.

2.6Non-Interchangeability with Other Formulations of Naproxen Different dose strengths and formulations (e.g., tablets, suspension) of naproxen are not interchangeable. This difference should be taken into consideration when changing st…

💊 Dosage Forms and Strengths 104 words ▾

3 DOSAGE FORMS AND STRENGTHS Naproxen Tablets USP, 250 mg are yellow colored mottled, biconvex, beveled edged round shape, uncoated tablets debossed with ‘T’ & ‘18’ on either side of breakline on one side and other side plain. Naproxen Tablets USP, 375 mg are yellow colored mottled, biconvex, oval shaped, uncoated tablets debossed with ‘T’ & ‘19’ on one side and other side plain. Naproxen Tablets USP, 500 mg are yellow colored mottled, biconvex, capsule shaped, uncoated tablets debossed with ‘T’ & ‘20’ on either side of breakline on one side and other side plain.

Naproxen tablets: 250 mg, 375 mg and 500 mg

⛔ Contraindications 127 words ▾

4 CONTRAINDICATIONS Naproxen tablets are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [see Warnings and Precautions (5.7 , 5.9 )] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7 , 5.8 )] In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ] Known hypersensitivity to naproxen 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 naproxen 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 naproxen 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 : Naproxen is contraindicated in patients with aspirin-sensitive asthma.

Monitor patients with preexisting asthma (without aspirin sensitivity). ( 5.8 ) Serious Skin Reactions : Discontinue naproxen 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 naproxen, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus. ( 5.11 , 8.1 ) Hematologic Toxicity : Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.

( 5.12 , 7 )

5.1Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.

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

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

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as naproxen, 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 Registry have demonstrated that patie…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of 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 to naproxen were dyspepsia, abdominal pain, nausea, headache, rash, ecchymosis, and edema.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 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 reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis or osteoarthritis are listed below. In general, reactions in patients treated chronically were reported 2 to 10 times more frequently than they were in short-term studies in the 962 patients treated for mild to moderate pain or for dysmenorrhea.

The most frequent complaints reported related to the gastrointestinal tract. A clinical study found gastrointestinal reactions to be more frequent and more severe in rheumatoid arthritis patients taking daily doses of 1500 mg naproxen compared to those taking 750 mg naproxen. In controlled clinical trials with about 80 pediatric patients and in well-monitored, open-label studies with about 400 pediatric patients with polyarticular juvenile idiopathic arthritis treated with naproxen, the incidence of rash and prolonged bleeding times were greater, the incidence of gastrointestinal and central nervous system reactions were about the same, and the incidence of other reactions were lower in pediatric patients than in adults.

In patients taking naproxen in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients were: Gastrointestinal (GI) Experiences, including: heartburn*, abdominal pain*, nausea*, constipation*, diarrhea, dyspepsia, stomatitis Central Nervous System: headache*, dizziness*, drowsiness*, lightheadedness, vertigo Dermatologic: pruritus (itching)*, skin eruptions*, ecchymoses*, sweating, purpura Special Senses : tinnitus*, visual disturbances, hearing disturbances Cardiovascular: edema*, palpitations General: dyspnea*, thirst *Incidence of reported reaction between 3% and 9%.

Those reactions occurring in less than 3% of the patients are unmarked. In patients taking NSAIDs, the following adverse experiences have also been reported in approximately 1% to 10% of patients. Gastrointestinal (GI) Experiences, including: flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting General: abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashes The following are additional adverse experiences reported in <1% of patients taking naproxen during clinical trials.

Gastrointestinal: pancreatitis, vomiting Hepatobiliary: jaundice Hemic and Lymphatic: melena, thrombocytopenia, agranulocytosis Nervous System: inability to concentrate Dermatologic: skin rashes

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of naproxen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to dr…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS See Table 2 for clinically significant drug interactions with naproxen. Table 2: Clinically Significant Drug Interactions with naproxen Drugs That Interfere with Hemostasis Clinical Impact: Naproxen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of naproxen 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 naproxen with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see Warnings and Precautions (5.12) ] .

Aspirin Clinical Impact: A pharmacodynamic (PD) study has demonstrated an interaction in which lower dose naproxen (220 mg/day or 220 mg twice daily) interfered with the antiplatelet effect of low-dose immediate-release aspirin, with the interaction most marked during the washout period of naproxen (see

12.2Pharmacodynamics ). There is reason to expect that the interaction would be present with prescription doses of naproxen or with enteric-coated low-dose aspirin; however, the peak interference with aspirin function may be later than observed in the PD study due to the longer washout period. 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: Because there may be an increased risk of cardiovascular events following discontinuation of naproxen due to the interference with the antiplatelet effect of aspirin during the washout period, for patients taking low-dose aspirin for cardioprotection who require intermittent analgesics, consider use of an NSAID that does not interfere with the antiplatelet effect of aspirin, or non-NSAID analgesics where appropriate.

Concomitant use of naproxen and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see Warnings and Precautions (5.12) ] . Naproxen is not substitutes for low dose aspirin for cardiovascular protection. ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).

In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Intervention: During concomitant use of naproxen and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.

During concomitant use of naproxen 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., furose…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Infertility : NSAIDs are associated with reversible infertility. Consider withdrawal of naproxen in women who have difficulties conceiving. ( 8.3 ) 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). ( 8.7 )

8.1Pregnancy Risk Summary Use of NSAIDs, including naproxen, 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 naproxen use between about 20 and 30 weeks of gestation, and avoid naproxen 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 naproxen, 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 in rats, rabbits, and mice no evidence of teratogenicity or fetal harm when naproxen was administered during the period of organogenesis at doses 0.13, 0.26, and 0.6 times the maximum recommended human daily dose of 1500 mg/day, respectively [ see Data ].

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

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

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including naproxen, 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 naproxen treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue naproxen, and follow up according to clinical practice (see Data ). Labor or Delivery There are no studies on the effects of naproxen during labor or delivery.

In animal studies, NSAIDs, including naproxen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Human Data There is some evidence to suggest that when inhibitors of prostaglandin synthesis are used to delay preterm labor, there is an increased risk of neonatal complications such as necrotizing enterocolitis, patent ductus arteriosus, and intracranial hemorrhage. Naproxen treatment given in late pregnancy to delay parturition has been associated with persistent pulmonary hypertension, renal dysfunction, and abno…

🤰 Pregnancy ~3 min read ▾

Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly starting at 30-weeks of gestation, or third trimester) should be avoided. Premature Closure of Fetal Ductus Arteriosus: Published literature r…

🧒 Pediatric Use 94 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients below the age of 2 years have not been established. Pediatric dosing recommendations for polyarticular juvenile idiopathic arthritis are based on well-controlled studies [see Dosage and Administration (2) ]. There are no adequate effectiveness or dose-response data for other pediatric conditions, but the experience in polyarticular juvenile idiopathic arthritis and other use experience have established that single doses of 2.5 to 5 mg/kg as naproxen suspension, with total daily dose not exceeding 15 mg/kg/day, are well tolerated in pediatric patients over 2 years of age.

🧓 Geriatric Use ~2 min read ▾

8.5Geriatric Use The hepatic and renal tolerability of long-term naproxen administration was studied in two double-blind clinical trials involving 586 patients. Of the patients studied, 98 patients were age 65 and older and 10 of the 98 patients were age 75 and older. NAPROXEN was administered at doses of 375 mg twice daily or 750 mg twice daily for up to 6 months.

Transient abnormalities of laboratory tests assessing hepatic and renal function were noted in some patients, although there were no differences noted in the occurrence of abnormal values among different age groups. Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [see Warnings and Precautions (5.1 , 5.2 , 5.3 , 5.6 , 5.14) ].

Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. The clinical significance of this finding is unclear, although it is possible that the increase in free naproxen concentration could be associated with an increase in the rate of adverse events per a given dosage in some elderly patients. 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. Experience indicates that geriatric patients may be particularly sensitive to certain adverse effects of nonsteroidal anti-inflammatory drugs. Elderly or debilitated patients seem to tolerate peptic ulceration or bleeding less well when these events do occur.

Most spontaneous reports of fatal GI events are in the geriatric population [see Warnings and Precautions (5.2) ]. Naproxen is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Clinical Pharmacology (12.3) ] .

Geriatric patients may be at a greater risk for the development of a form of renal toxicity precipitated by reduced prostaglandin formation during administration of nonsteroidal anti-inflammatory drugs [see Warnings and Precautions (5.6) ].

🆘 Overdosage 203 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 )].

Because naproxen sodium may be rapidly absorbed, high and early blood levels should be anticipated. A few patients have experienced convulsions, but it is not clear whether or not these were drug-related. It is not known what dose of the drug would be life threatening. [see Warnings and Precautions (5.1 , 5.2 , 5.4 , 5.6 )].

Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage).

Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. 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 Naproxen has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of naproxen, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Naproxen is a potent inhibitor of prostaglandin synthesis in vitro .

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

12.2Pharmacodynamics In a healthy volunteer study, 10 days of concomitant administration of naproxen 220 mg once-daily with low-dose immediate-release aspirin (81 mg) showed an interaction with the antiplatelet activity of aspirin as measured by % serum thromboxane B2 inhibition at 24 hours following the day 10 dose [98.7% (aspirin alone) vs 93.1% (naproxen and aspirin)]. The interaction was observed even following discontinuation of naproxen on day 11 (while aspirin dose was continued) but normalized by day 13. In the same study, the interaction was greater when naproxen was administered 30 minutes prior to aspirin [98.7% vs 87.7%] and minimal when aspirin was administered 30 minutes prior to naproxen [98.7% vs 95.4%].

Following administration of naproxen 220 mg twice-daily with low-dose immediate-release aspirin (first naproxen dose given 30 minutes prior to aspirin), the interaction was minimal at 24 h following day 10 dose [98.7% vs 95.7%]. However, the interaction was more prominent after discontinuation of naproxen (washout) on day 11 [98.7% vs 84.3%] and did not normalize completely by day 13 [98.5% vs 90.7%]. [see Drug Interactions (7) ] .

12.3Pharmacokinetics Naproxen and naproxen sodium are rapidly and completely absorbed from the gastrointestinal tract with an in vivo bioavailability of 95%. The different dosage forms of naproxen are bioequivalent in terms of extent of absorption (AUC) and peak concentration (C max ); however, the products do differ in their pattern of absorption. These differences between naproxen products are related to both the chemical form of naproxen used and its formulation.

Even with the observed differences in pattern of absorption, the elimination half-life of naproxen is unchanged across products ranging from 12 to 17 hours. Steady-state levels of naproxen are reached in 4 to 5 days, and the degree of naproxen accumulation is consistent with this half-life. This suggests that the differences in pattern of release play only a negligible role in the attainment of steady-state plasma levels.

Absorption After administration of naproxen tablets, peak plasma levels are attained in 2 to 4 hours. When naproxen tablets were given to fasted subjects (n=24) in a crossover study following 1 week of dosing, differences in time to peak plasma levels (T max ) were observed, but there were no differences in total absorption as measured by C max and AUC: Naproxen Tablets * 500 mg bid C max (mcg/mL) 97.4 (13%) T max (hours) 1.9 (61%) AUC 0–12 hr (mcg·hr/mL) 767 (15%) *Mean value (coefficient of variation) Distribution Naproxen has a volume of distribution of

0.16L/kg. At therapeutic levels naproxen is greater than 99% albumin-bound. At doses of naproxen greater than 500 mg/day there is less than proportional increase in plasma levels due to an increase in clearance caused by saturation of plasma protein binding at higher doses (average trough C ss 36.5, 49.2 and 56.4 mg/L with 500, 1000 and 1500 mg daily doses of naproxen, respectively).

The naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma [see Use in Specific Populations (8.2) ] . Elimination Metabolism Naproxen is extensively metab…

🧬 Mechanism of Action 99 words ▾

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

📦 How Supplied / Storage and Handling 167 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Naproxen Tablets USP, 250 mg are yellow colored mottled, biconvex, beveled edged round shape, uncoated tablets debossed with ‘T’ & ‘18’ on either side of breakline on one side and other side plain. Bottles of 100 NDC 65862-520-01 Bottles of 500 NDC 65862-520-05 Bottles of 1,000 NDC 65862-520-99 10 x 10 Unit-dose Tablets NDC 65862-520-10 Naproxen Tablets USP, 375 mg are yellow colored mottled, biconvex, oval shaped, uncoated tablets debossed with ‘T’ & ‘19’ on one side and other side plain.

Bottles of 100 NDC 65862-521-01 Bottles of 500 NDC 65862-521-05 Bottles of 1,000 NDC 65862-521-99 Naproxen Tablets USP, 500 mg are yellow colored mottled, biconvex, capsule shaped, uncoated tablets debossed with ‘T’ & ‘20’ on either side of breakline on one side and other side plain. Bottles of 100 NDC 65862-522-01 Bottles of 500 NDC 65862-522-05 Bottles of 2,500 NDC 65862-522-26 Store at 20° to 25°C (68° to 77°F) in well-closed containers [see USP Controlled Room Temperature]. Dispense in light-resistant containers.

📋 Description 147 words ▾

11 DESCRIPTION Naproxen tablets, USP are nonsteroidal anti-inflammatory drugs available as follows: Naproxen tablets, USP are available as yellow tablets containing 250 mg, 375 mg and 500 mg of naproxen USP for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid.

It has the following structural formula: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen USP is a white to off-white, practically odorless, crystalline powder. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH.

The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The inactive ingredients in naproxen tablets include: corn starch, ferric oxide, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate. Chemical Structure

💬 Information for Patients ~2 min read ▾

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

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

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

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

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

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

279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 05/2025

💬 Medication Guide ~3 min read ▾

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

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

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take NSAIDs? Do not take NSAIDs: if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. right before or after heart bypass surgery.

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

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

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

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

Glossary — plain-language definitions of medical terms used in this label:

antiplatelet: A medicine that makes platelets, the blood cells that start a clot, less likely to clump together.

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

synergistic: When two things taken together produce a larger effect than adding their separate effects would predict.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose-response: The relationship between the size of a dose and the strength of the body's reaction to it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

ecchymosis: A bruise; a flat blue or purple mark on the skin where blood has leaked underneath.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

enteric-coated: A special coating that keeps a pill from dissolving in the stomach, so it opens up further along in the intestine.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

fertility: The natural ability to become pregnant or to father a child.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

gastrointestinal bleeding: Bleeding anywhere along the digestive tract, from the food pipe down to the bowel.

gout: A type of arthritis with sudden, painful, swollen joints caused by uric acid crystals.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hematemesis: Vomiting blood, which may look bright red or like dark coffee grounds.

hematocrit: A blood test showing what share of your blood is made up of red blood cells.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemoglobin: The iron-containing protein inside red blood cells that carries oxygen throughout the body.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperkalemia: A higher-than-normal level of potassium, an important mineral, in the blood.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

immediate-release: A standard pill or capsule that releases all of its medicine soon after it is swallowed.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

melena: Black, sticky, tar-like stools caused by blood that has been digested higher up in the gut.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

perforation: A hole that forms all the way through the wall of the stomach or intestine.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

pruritus: Itching of the skin.

pulmonary hypertension: High blood pressure in the arteries that carry blood from the heart to the lungs.

purpura: Purple spots or patches on the skin caused by bleeding just under the surface.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

stillbirth: The death of a baby in the womb late in pregnancy or during birth.

stomatitis: Soreness, swelling, or sores on the lining inside the mouth.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

synergistic effect: When two medicines taken together produce a combined effect that is greater than simply adding their separate effects.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

trough: The lowest level a medicine reaches in the blood, just before the next dose is due.

ulceration: The forming of an open sore on the skin or on a lining inside the body, such as the stomach.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

washout period: A stretch of time in a study with no medicine, letting earlier drugs clear the body before the next phase.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

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

← 65862-0521-01 · Aurobindo 65862-0523-01 · Aurobindo →

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.

Naproxen 500 mg Tablet, 500-count

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