NDC 0003-0315 Kenalog-80
Triamcinolone Acetonide Injection, Suspension Intra-articular; Intramuscular

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 0003-0315?
    4. Kenalog-80 Uses
    5. Active Ingredients
    6. NDC to RxNorm Crosswalk
    7. Pharmacologic Classes

Product Information

NDC Product Code0003-0315
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.		Kenalog-80
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.		Triamcinolone Acetonide
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.		Triamcinolone Acetonide
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 INCLUDED in the NDC Directory
Dosage FormInjection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Intra-articular - Administration within a joint.
  • Intramuscular - Administration within a muscle.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		E.r. Squibb & Sons, L.l.c.
Labeler Code0003
SPL SET ID:cf970688-cd77-b95c-4bd9-c541590e9722
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.		NDA014901
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.		NDA - A product marketed under an approved 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.		04-12-2019
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.		12-31-2023
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 Packages

NDC Code 0003-0315-05

Package Description: 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE

NDC Code 0003-0315-20

Package Description: 1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE

Product Details

What is NDC 0003-0315?

The NDC code 0003-0315 is assigned by the FDA to the product Kenalog-80 which is a human prescription drug product labeled by E.r. Squibb & Sons, L.l.c.. The generic name of Kenalog-80 is triamcinolone acetonide. The product's dosage form is injection, suspension and is administered via intra-articular; intramuscular form. The product is distributed in 2 packages with assigned NDC codes 0003-0315-05 1 vial, single-dose in 1 carton / 1 ml in 1 vial, single-dose, 0003-0315-20 1 vial, multi-dose in 1 carton / 5 ml in 1 vial, multi-dose. 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 Kenalog-80?

This medication is used in a variety of conditions such as allergic disorders, arthritis, gout, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders, collagen and skin diseases. Talk to your doctor about the risks and benefits of triamcinolone, especially if it is to be injected near your spine (epidural). Rare but serious side effects may occur with epidural use. Triamcinolone is known as a corticosteroid hormone (glucocorticoid). It works by decreasing your body's immune response to these diseases and reduces symptoms such as swelling.

What are Kenalog-80 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.
  • TRIAMCINOLONE ACETONIDE 80 mg/mL - An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.

What is the NDC to RxNorm Crosswalk for Kenalog-80?

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 indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Which are the Pharmacologic Classes for Kenalog-80?

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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