Animal NDC 54771-1003-2 Aureomycin

Chlortetracycline Hydrochloride

Animal NDC Product Code 54771-1003-2

Field Name Field Value
Animal NDC Code 54771-1003-2
Proprietary Name Aureomycin 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 Hydrochloride 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 Hydrochloride
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 NADA048761 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.

Aureomycin 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

Active Drug Ingredient

Chlortetracycline calcium complex equivalent to 100 g chlortetracycline hydrochloride per lb.

Ingredients

Dried Streptomyces aureofaciens Fermentation Product and Calcium Sulfate.

Use Directions

Mix sufficient Aureomycin 100 Granular Medicated Article to supply desired concentration of chlortetracycline per ton with part of the feed ingredients to make a preblend. Add the remainder of the ingredients and mix thoroughly. For specific use levels, see Indications for use.

Mixing Directions

Level desired grams per tonAmount of medicated article per ton*501/2 lb1001 lb2002 lb4004 lb5005 lb† It is recommended that 1 pound of Aureomycin 100 Granular Type A Medicated Article be diluted with 3 pounds of one of the feed ingredients to form a 4 pound working premix. Use 2 pounds of the working premix to make a preblend (see Use directions) for a Type C feed containing 50 g Aureomycin chlortetracycline / ton of feed.

Indications For Use

Indications for use Chlortetracyclinemg per lb bodywt per day Cattle    Beef Cattle (over 700 lb): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. 0.5    Beef and Non-Lactating Dairy Cattle: As an aid in control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline when delivered in a free-choice feed.  Free-choice feed must be manufactured  under a medicated feed mill license utilizing an FDA approved formulation. 0.5-2.0    Calves, Beef and Non-Lactating Dairy Cattle: Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline. Feed for not more than 5 days. The appropriate amount of Aureomycin-containing feed supplement may be mixed in the cattle's daily ration or administered as a top-dress. If the Aureomycin-containing feed supplement is administered as a top-dress, it must be spread uniformly on top of the ration and sufficient space must be provided so that all cattle can eat at the same time. 10  Swine Control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline.Treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline. (Note: this drug level is equivalent to approximately 400 grams per ton, depending on feed consumption and body weight.)Feed for not more than 14 days. 10  Turkeys Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to chlortetracycline. Feed continuously for 7 to 14 days. 25   Indications mg per headper dayCattle     Growing Cattle (over 400 lb): For the reduction of  the incidence of liver abscesses. 70    Beef Cattle and Dairy Replacement Heifers: Control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline. 350    Beef Cattle (under 700 lb): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. 350  Sheep Breeding Sheep: Reduction in the incidence of (vibrionic) abortions caused by Campylobacter fetus infection susceptible to chlortetracycline. 80   Indications for use In complete feedChlortetracyclineg per ton   Swine Reduction in the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci susceptible to chlortetracycline. 50-100    Breeding Swine: Control of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline. Feed continuously for not more than 14 days. 400  Ducks Control and treatment of fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline. Feed in complete ration to provide from 8 to 28 mg per pound of body weight per day depending upon age and severity of disease. Feed for not more than 21 days. 200-400  Chickens Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.Feed continuously for 7 to 14 days. 100-200    Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to chlortetracycline.Feed continuously for 7 to 14 days. 200-400    Reduction of mortality due to Escherichia coli infections susceptible to chlortetracycline. Feed for 5 days. 500  Turkeys Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. Feed continuously for 7 to 14 days. 200    Control of hexamitiasis caused by Hexamita meleagridis susceptible to chlortetracycline. Feed continuously for 7 to 14 days. 400    Turkey Poults not over 4 weeks of age: Reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline. 400  Indications for use mg per g feedPsittacine birds Warning: Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals and man. Contact appropriate public health and regulatory officials. Caution: Aspergilliosis may occur following prolonged treatment.     Treatment of psittacine birds (parrots, macaws, cockatoos) suspected or known to be infected with psittacosis caused by Chlamydia psittaci sensitive to chlortetracycline. Feed continuously for 45 days. Each bird should consume an amount of medicated feed equal to one-fifth of its body weight daily. During treatment, parrots, macaws, and cockatoos should be kept individually or in pairs in clean cages. 10

Withdrawal Periods And Residue Warnings

No withdrawal period is required when used according to labeling. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to ducks or turkeys producing eggs for human consumption.

Storage

Store below 25°C (77°F), excursions permitted to 37°C (99°F)Restricted Drug (California) - Use only as directed. Not for use in humans. Keep out of reach of children.Approved by FDA under NADA # 048-761

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