NDC 27854-505-01 Flanax Pain Reliever/fever Reducer

Naproxen Sodium

NDC Package Code 27854-505-01

The NDC Code 27854-505-01 is assigned to a package of 1 bottle in 1 carton > 24 tablet, coated in 1 bottle of Flanax Pain Reliever/fever Reducer, a human over the counter drug labeled by Belmora Llc. The product's dosage form is tablet, coated and is administered via oral form.

Field Name Field Value
NDC Code 27854-505-01
Package Description 1 BOTTLE in 1 CARTON > 24 TABLET, COATED in 1 BOTTLE
Proprietary Name Flanax Pain Reliever/fever Reducer 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.
Drug Uses Naproxen is used to relieve pain from various conditions. It also reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section. Some brands of sustained-release naproxen take longer to be absorbed and are not recommended for pain that needs quick relief (such as during a gout attack). Ask your doctor or pharmacist if you have questions about your particular brand.
11-Digit NDC Billing Format 27854050501 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Product Type Human Otc 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.
Labeler Name Belmora Llc
Dosage Form Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route(s)
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
  • NAPROXEN SODIUM 220 mg/1
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
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.
FDA Application Number ANDA090545 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.
Start Marketing Date 05-15-2020 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 12-31-2021 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

NDC Code Structure

  • 27854 - Belmora Llc
    • 27854-505 - Flanax Pain Reliever/fever Reducer
      • 27854-505-01 - 1 BOTTLE in 1 CARTON

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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Other Product Packages

The following packages are also available for Flanax Pain Reliever/fever Reducer with product NDC 27854-505.

NDC Package CodePackage Description
27854-505-021 BOTTLE in 1 CARTON > 2 TABLET, COATED in 1 BOTTLE

* Please review the disclaimer below.