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NDC 63868-0465-50 Naproxen Sodium 220 mg/1 Details

Naproxen Sodium 220 mg/1

Naproxen Sodium is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association. The primary component is NAPROXEN SODIUM.

MedlinePlus Drug Summary

Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine). Prescription naproxen tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of the tissue that connects muscle to bone), gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints), and pain from other causes, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription naproxen is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Naproxen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Related Packages: 63868-0465-50
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Naproxen

Product Information

NDC	63868-0465
Product ID	63868-465_94202ade-aee5-8c94-e053-2a95a90ac749
Associated GPIs	66100060100303
GCN Sequence Number	021980
GCN Sequence Number Description	naproxen sodium TABLET 220 MG ORAL
HIC3	S2B
HIC3 Description	NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS
GCN	47132
HICL Sequence Number	003726
HICL Sequence Number Description	NAPROXEN SODIUM
Brand/Generic	Generic
Proprietary Name	Naproxen Sodium
Proprietary Name Suffix	n/a
Non-Proprietary Name	NAPROXEN SODIUM
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, COATED
Route	ORAL
Active Ingredient Strength	220
Active Ingredient Units	mg/1
Substance Name	NAPROXEN SODIUM
Labeler Name	Chain Drug Marketing Association
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA079096
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63868-0465-50 (63868046550)

Pricing Information
NDC Package Code	63868-465-50
Billing NDC	63868046550
Package	1 BOTTLE, PLASTIC in 1 CARTON (63868-465-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Start Date	2009-09-03
NDC Exclude Flag	N
Price Per Unit	0.06477
Pricing Unit	EA
Effective Date	2022-11-23
NDC Description	QC NAPROXEN SOD 220 MG TABLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2022-11-23

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL d9e72c3f-addc-4391-a7a4-2680a3e7f5c4 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID 1)

1: nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

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

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
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time 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

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, or kidney disease
you are taking a diuretic
you have asthma
you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are

under a doctor's care for any serious condition
taking any other drug

When using this product

take with food or milk if stomach upset occurs
long term continuous use may increase the risk of heart attack or stroke

Stop use and ask a doctor if

side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
you have difficulty swallowing
it feels like the pill is stuck in your throat
you develop heartburn
redness or swelling is present in the painful area
any new symptoms appear

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 right away.

Directions

do not take more than directed
the smallest effective dose should be used
do not take longer than 10 days, unless directed by a doctor (see Warnings)
drink a full glass of water with each dose

adults and children 12 years and older	take 1 tablet 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

Other information

each tablet contains: sodium 20 mg
store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
retain carton for complete product information

Inactive ingredients

croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

PRINCIPAL DISPLAY PANEL

NDC 63868-465-50

QUALITY CHOICE

†Compare to the active ingredient in ALEVE®

Naproxen Sodium

Non-Prescription Strength

Naproxen Sodium Tablets, 220mg

Pain Reliever / Fever Reducer (NSAID)

50 Tablets

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM

naproxen sodium tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-465
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN SODIUM	220 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	I3
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-465-50	1 in 1 CARTON	09/03/2009
1		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:63868-465-01	1 in 1 CARTON	09/03/2009
2		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079096	09/03/2009

Labeler - Chain Drug Marketing Association (011920774)

Revised: 10/2019

Document Id: 94202ade-aee5-8c94-e053-2a95a90ac749

Set id: d9e72c3f-addc-4391-a7a4-2680a3e7f5c4

Version: 2

Effective Time: 20191004