Animal NDC 54771-8449-1 Albon Bolus

Sulfadimethoxine

Animal NDC Product Code 54771-8449-1

Field Name Field Value
Animal NDC Code 54771-8449-1
Proprietary Name Albon Bolus 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 Sulfadimethoxine 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 Otc Animal Drug
Active Ingredient(s)
  • Sulfadimethoxine
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 NADA031715 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.

Albon Bolus 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

Other

Boluses

Albon Boluses, 5 gDosage Schedule for Cattle: 200–600 lb of body weightAnimal Weight, lbFirst DayDaily for the Following 3–4 Days2001 bolus1/2 bolus3001 1/2 boluses1 bolus4002 boluses1 bolus5002 1/2 boluses1 1/2 boluses6003 boluses1 1/2 boluses

Albon Boluses, 15 gDosage Schedule for Cattle: 600–1,200 lb of body weightAnimal Weight, lbFirst DayDaily for the Following 3–4 Days6001 bolus1/2 bolus8001 1/2 boluses1 bolus1,000-1,2002 boluses1 bolus

Restricted Drug (California)—Use Only as DirectedNADA #31-715, Approved by FDADistributed by:Zoetis Inc.Kalamazoo, MI 4900713904000Revised: January 2013

Description

DESCRIPTION: Albon is a low-dose, rapidly absorbed, long-acting sulfonamide.

Mechanism Of Action

Actions: Sulfadimethoxine has been demonstrated in laboratory studies to be effective against a wide variety of organisms, such as streptococci, staphylococci, and members of the E. coli-salmonella group of bacteria.Comparatively low doses of Albon give rapid, sustained blood levels required for effective disease therapy.

Veterinary Indications

INDICATIONS AND USAGE: Albon is effective in the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum sensitive to sulfadimethoxine in cattle.

Warnings

WARNINGS:Not for Human UseMilk taken from animals during treatment and for 60 hours (5 milkings) after the latest treatment must not be used for food.Do not slaughter animals for food purposes within 7 days following the last treatment.A withdrawal period has not been established for this product in preruminating calves.Do Not Use in Calves to be Processed for Veal

Precautions

PRECAUTIONS: During treatment period, make certain that animals maintain adequate water intake.If animals show no improvement within 2–3 days, reevaluate your diagnosis. Treatment should not be continued beyond 5 days.

Dosage & Administration

DOSAGE AND ADMINISTRATION: Albon should be administered to cattle so that the initial dose is equivalent to 25 mg/lb of body weight and each subsequent daily dose is equivalent to 12.5 mg/lb of body weight. Length of treatment will depend on clinical response. In most cases, treatment for 3–4 days is adequate. Treatment should not be continued beyond 5 days.The following tables show the dosage and dosage forms to be used for cattle of different weights.

Animal Pharmacology & Or Toxicology

TOXICITY AND SAFETY: Albon has been shown to be a well-tolerated sulfonamide with relatively high solubility at the pH normally occurring in the kidney and with a low degree of tox- icity. Following the administration of Albon at the recommended dosage, no undesirable side effects have been observed.

Storage And Handling

Store at Controlled Room Temperature 15°–30°C (59°–86°F)

How Supplied

HOW SUPPLIED: Albon Boluses are supplied in the following dosage forms:5 g sulfadimethoxine per single-scored bolus15 g sulfadimethoxine per single-scored bolus

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

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