Animal NDC 54771-1018-5 Aureomix S 40/40 Granular

Chlortetracycline And Sulfamethazine

Animal NDC Product Code 54771-1018-5

Field Name Field Value
Animal NDC Code 54771-1018-5
Proprietary Name Aureomix S 40/40 Granular 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 Chlortetracycline And Sulfamethazine 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 Zoetis Inc.
Product Type Vfd Type A Medicated Article Animal Drug
Active Ingredient(s)
  • Chlortetracycline
  • Sulfamethazine
Inactive Ingredient(s)
  • CALCIUM SULFATE (WAT0DDB505)
  • CALCIUM SULFATE (WAT0DDB505)
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 NADA035688 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.

Aureomix S 40/40 Granular Animal Product Label Images

Aureomix S 40/40 Granular 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.

Product Labeling Index

Description

Chlortetracycline, sulfamethazineType A Medicated Article

Active Drug Ingredients

Chlortetracycline calcium complex equivalent to chlortetracycline HCI . . . 40 g/lbSulfamethazine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.8% (40 g/lb)

Ingredients

Calcium sulfate and dried Streptomyces aureofaciens fermentation product.

Indications

For use in the manufacture of swine feedsFor reduction of the incidence of cervical abscesses; treatment of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery); prevention of these diseases during times of stress; and maintenance of weight gains in the presence of atrophic rhinitis.

Mixing Directions

Use 2.5 lb Aureomix® S 40/40 Granular per 1 ton (907.2 kg) of final feed. Make a preblend of 2.5 lb of Aureomix® S 40/40 Granular with part (15-20 lb) of the feed ingredients. Mix thoroughly with the remainder of the ingredients to give a final concentration of 100 g chlortetracycline and 100 g sulfamethazine per ton of feed.

Warning

Withdraw 15 days prior to slaughter

Storage

Store below 25°C (77°F), excursions permitted to 37°C (99°F).Restricted Drug (California) - use only as directed. Not for human use.NADA #35-688, Approved by FDA Distributed by:Zoetis Inc.Kalamazoo, MI 49007Net wt 50 LB (22.68 kg)10006101

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