1. Home
  2. Animal Drug Index - D
  3. Denagard 80 Coated Type A Medicated Article

Animal NDC 58198-9413-1 Denagard 80 Coated Type A Medicated Article

Tiamulin Fumarate

Animal Product Information

Field Name Field Value
Animal NDC Code 58198-9413-1
Proprietary Name Denagard 80 Coated Type A Medicated Article 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 Tiamulin Fumarate 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.
Labeler Name Elanco Us Inc.
Product Type Otc Animal Drug
Usage Information
    For treatment of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to Tiamulin; For control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis; For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to Tiamulin.
Active Ingredient(s)
  • Tiamulin Fumarate
Marketing Category NADA - NEW ANIMAL 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 NADA139472 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.

Denagard 80 Coated Type A Medicated Article Images

Denagard 80 Coated Type A Medicated Article Animal 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.

Table of Contents



Other



Coated (tiamulin hydrogen fumarate)

Type A Medicated Article

For the manufacture of Denagard 10

Type B Medicated Swine Feed only.

Not to be used for the manufacture of

Type C medicated feeds.


Active Ingredient:



tiamulin hydrogen fumarate:

80% w/w (363.2 g/lb.)


Inactive Ingredients:



porcine gelatin


Indications:



For treatment of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to Tiamulin; For control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis; For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to Tiamulin.


Warnings:



Denagard 10 Type B Medicated Swine Feed label contains residue information for use in swine.

Keep out of reach of children.

lrritating to eyes and respiratory system.

May cause sensitization by inhalation and skin contact. Do not breathe dust.

Avoid contact with skin and eyes.

Wear suitable protective clothing and gloves.

Caution:

Do not feed undiluted. Do not use in feeds for animals other than swine. The effects of tiamulin on swine reproductive performance, pregnancy and lactation have not been determined. Swine being treated with Denagard (tiamulin) should not have access to feeds containing polyether ionophores (e.g., lasalocid, monensin, narasin, salinomycin and semduramicin) as adverse reactions may occur. If signs of toxicity occur, discontinue use.


Storage:



Protect from light and moisture. Store at or below 25°C (77°F). Temporary excursions to 40°C (104°F) permitted.

Directions For Preparation of Denagard 10 Type B Medicated Swine Feed.

Ingredient:

Denagard 80%
Coated (tiamulin
hydrogen fumarate)

Rice Hulls

Mineral Oil

Quantity per 2000 lbs.:

56.2 lbs.*

1863.8 lbs.

80 lbs.

With mixer on, dispense mineral oil into rice hulls. Mix until sufficiently blended. Add Denagard 80% Coated (tiamulin hydrogen fumarate) to mixture while mixer is running. Mix until homogeneous.

* Includes 2% overage.

Restricted Drug (California):

Use only as directed.

For more information or to report adverse effects, call Elanco US Inc. at 1-800-428-4441.

For a complete listing of adverse reactions for DENAGARD reported to CVM see:

www.fda.gov/reportanimalae

Manufactured for:
Elanco US Inc.
Greenfield, IN 46140 USA

Product of Italy

Lot Number:

Date of
Manufacture:

Date of
Expiration:

Denagard, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

© 2023 Elanco or its affiliates

Approved by FDA under NADA # 139-472

YL240600X

Elanco™


Principal Display Panel - 22 G In 1 Kg Bag Label



Net Weight:
55 lb (25 kg)
Denagard™ 80%
Coated (tiamulin hydrogen fumarate)
Type A Medicated Article
Approved by FDA under NADA # 139-472


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.