NDC 80425-0281 Celecoxib
Capsule Oral

Product Information

NDC Product Code80425-0281
Proprietary Name 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.		Celecoxib
Non-Proprietary Name 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.		Celecoxib
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Celecoxib
Product Type 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.		Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT and included in NDC Directory
Dosage FormCapsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
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.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Advanced Rx Pharmacy Of Tennessee, Llc
Labeler Code80425
SPL SET ID:f60394f5-fd69-929b-e053-2995a90a5793
FDA Application Number 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.		ANDA210628
Marketing Category 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.		ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-03-2023
Listing Expiration Date 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.		12-31-2024
Exclude Flag 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". 		N
NDC Code Structure

Product Characteristics

Color(s)WHITE (C48325 - (WHITE OPAQUE))
ShapeCAPSULE (C48336)
Size(s)18 MM
Imprint(s)CEL;200MG
Score1

Product Packages

NDC Code 80425-0281-1

Package Description: 30 CAPSULE in 1 BOTTLE

NDC Code 80425-0281-2

Package Description: 60 CAPSULE in 1 BOTTLE

NDC Code 80425-0281-3

Package Description: 90 CAPSULE in 1 BOTTLE

NDC Code 80425-0281-4

Package Description: 180 CAPSULE in 1 BOTTLE

Product Details

What is NDC 80425-0281?

The NDC code 80425-0281 is assigned by the FDA to the product Celecoxib which is a human prescription drug product labeled by Advanced Rx Pharmacy Of Tennessee, Llc. The product's dosage form is capsule and is administered via oral form. The product is distributed in 4 packages with assigned NDC codes 80425-0281-1 30 capsule in 1 bottle , 80425-0281-2 60 capsule in 1 bottle , 80425-0281-3 90 capsule in 1 bottle , 80425-0281-4 180 capsule in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Celecoxib?

This medication is a nonsteroidal anti-inflammatory drug (NSAID), specifically a COX-2 inhibitor, which relieves pain and swelling (inflammation). It is used to treat arthritis, acute pain, and menstrual pain and discomfort. The pain and swelling relief provided by this medication helps you perform more of your normal daily activities. 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. This drug works by blocking the enzyme in your body that makes prostaglandins. Decreasing prostaglandins helps to reduce pain and swelling.

What are Celecoxib Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • CELECOXIB 200 mg/1 - A pyrazole derivative and selective CYCLOOXYGENASE 2 INHIBITOR that is used to treat symptoms associated with RHEUMATOID ARTHRITIS; OSTEOARTHRITIS and JUVENILE ARTHRITIS, as well as the management of ACUTE PAIN.

Which are Celecoxib UNII Codes?

The UNII codes for the active ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Celecoxib?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:

Which are the Pharmacologic Classes for Celecoxib?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product Label

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