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Naproxen Sodium

ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Naproxen Sodium
Generic name
Naproxen Sodium
Dosage form
Capsule
Route
—
Marketing category
DRUG FOR FURTHER PROCESSING · BULK API
Labeler
Patheon Softgels Inc.
Product type
Drug For Further Processing
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
5
Packages
5
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Naproxen Sodium 220 mg/1 849431 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule
Route of administration
—
Presentations
10

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Anti-Inflammatory Agents EPC All 251 members
Cyclooxygenase Inhibitors [MoA] MoA All 251 members
Non-Steroidal [CS] CS All 251 members
Nonsteroidal Anti-inflammatory Drug [EPC] EPC All 251 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
202807
Application type
ANDA · Abbreviated New Drug Application
Approval date
January 4, 2019
Sponsor
CATALENT
Products on application
1
Submissions recorded
5
Products approved under application 202807.
Product Trade name Form Strength Ingredient Status TE Flags
202807-001 NAPROXEN SODIUM CAPSULE NAPROXEN SODIUM Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 202807.
Type No. Action Status Date Review
Supplement 8 Labeling Approved September 19, 2023 Standard
Supplement 7 Labeling Approved September 19, 2023 Standard
Supplement 3 Labeling Approved April 9, 2020 Standard
Supplement 2 Labeling Approved April 9, 2020 Standard
Original application 1 Approved January 4, 2019 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251117). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251117

Indications and Usage

openFDA Drug Labeling

Uses temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever

Purposes Pain reliever/fever reducer

Dosage and Administration

openFDA Drug Labeling

Directions do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose if taken with food, this product may taken longer to work adults and children 12 years and older: take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets within the first hour do not exceed 2 tablets in any 8- to 12-hour period do not exceed 3 tablets in a 24-hour period children under 12 years: ask a doctor

Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug have 3 or more alcoholic drinks every day while using this product take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) take more or for a longer time than directed Heart attack and stroke warning : NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you have problems or serious side effects from taking pain relievers or fever reducers you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better you have symptoms of heart problem or stroke: chest pain slurred speech leg swelling trouble breathing weakness in one part or side of the body pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear you have difficulty swallowing it feels like the pill is stuck in your throat If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you have problems or serious side effects from taking pain relievers or fever reducers you are taking a diuretic

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better you have symptoms of heart problem or stroke: chest pain slurred speech leg swelling trouble breathing weakness in one part or side of the body pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear you have difficulty swallowing it feels like the pill is stuck in your throat

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each capsule) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Adverse event reports

Source: openFDA FAERS
165,056
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: NAPROXEN SODIUM. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
49588-0003-1 49588-0003 Catalent Argentina S.A.I.y C. 1 BAG in 1 BOX (49588-0003-1) / 6000 CAPSULE in 1 BAG February 28, 2020
59726-751-20 59726-751 P & L Development, LLC 1 BOTTLE, PLASTIC in 1 BOX (59726-751-20) / 20 CAPSULE in 1 BOTTLE, PLASTIC December 4, 2020
10888-8115-1 10888-8115 Patheon Softgels Inc. 6000 CAPSULE in 1 BOX (10888-8115-1) January 1, 2018
10888-8129-1 10888-8129 Patheon Softgels Inc. 6000 CAPSULE in 1 BOX (10888-8129-1) November 6, 2014
10888-8130-1 10888-8130 Patheon Softgels Inc. 6000 CAPSULE in 1 BOX (10888-8130-1) June 3, 2010
49588-0003 49588-0003 Catalent Argentina S.A.I.y C. — February 28, 2020
59726-751 59726-751 P & L Development, LLC — December 4, 2020
10888-8115 10888-8115 Patheon Softgels Inc. — February 17, 2006
10888-8129 10888-8129 Patheon Softgels Inc. — February 17, 2006
10888-8130 10888-8130 Patheon Softgels Inc. — February 17, 2006

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.