NDC 72189-003 Naproxen Sodium

Naproxen Sodium

NDC Product Code 72189-003

NDC Code: 72189-003

Proprietary Name: Naproxen Sodium What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Naproxen Sodium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
BLUE (C48333 - (LIGHT BLUE))
Shape: OVAL (C48345)
Size(s):
12 MM
Imprint(s):
L368
Score: 1

NDC Code Structure

  • 72189 - Direct_rx
    • 72189-003 - Naproxen Sodium

NDC 72189-003-40

Package Description: 40 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Naproxen Sodium with NDC 72189-003 is a a human prescription drug product labeled by Direct_rx. The generic name of Naproxen Sodium is naproxen sodium. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Direct_rx

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Naproxen Sodium Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • NAPROXEN SODIUM 220 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • TALC (UNII: 7SEV7J4R1U)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POVIDONE (UNII: FZ989GH94E)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Nonsteroidal Anti-inflammatory Compounds - [Chemical/Ingredient]
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Direct_rx
Labeler Code: 72189
FDA Application Number: ANDA074661 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-21-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Naproxen Sodium Product Label Images

Naproxen Sodium Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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
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 are taking a diuretic



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
Stop use and ask a doctor if•

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



you have symptoms of heart problems or stroke:



chest pain



trouble breathing



weakness in one part or side of body



slurred speech



leg swelling



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



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. (1-800-222-1222)CLOSE

Inactive Ingredient

FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

* Please review the disclaimer below.

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