Animal NDC 54771-8783-1 Valbazen
Albendazole
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 54771-8783-1 |
| Proprietary Name | Valbazen 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 | Albendazole 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 |
| Usage Information |
|
| Active Ingredient(s) |
|
| Inactive Ingredient(s) |
|
| 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 | NADA110048 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. |
Valbazen 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
Indications
Cattle and sheep: Valbazen is a broad-spectrum anthelmintic effective in the removal and control of liver flukes, tapeworms, stomach worms (including 4th stage inhibited larvae of Ostertagia ostertagi), intestinal worms, and lungworms as indicated below.
Goats: For the treatment of adult liver flukes in nonlactating goats.
| Parasite | Cattle | Sheep | Goats |
|---|---|---|---|
| Adult Liver Flukes | Fasciola hepatica | Fasciola hepatica, Fascioloides magna | Fasciola hepatica |
| Heads and Segments of Tapeworms | Moniezia benedeni, M. expansa | Common Tapeworm (Moniezia expansa), Fringed Tapeworm (Thysanosoma actinioides) | |
| Adult and 4th Stage Larvae of Stomach Worms | Brown Stomach Worm, including 4th stage inhibited larvae (Ostertagia ostertagi), Barber Pole Worm (Haemonchus contortus, H. placei), Small Stomach Worm (Trichostrongylus axei) | Brown Stomach Worm (Ostertagia circumcincta, Marshallagia marshalli), Barber Pole Worm (Haemonchus contortus), Small Stomach Worm (Trichostrongylus axei) | |
| Adult and 4th Stage Larvae of Intestinal Worms | Thread-necked Intestinal Worm (Nematodirus spathiger, N. helvetianus), Small Intestinal Worm (Cooperia punctata, C. oncophora) | Thread-necked Intestinal Worm (Nematodirus spathiger, N. filicollis), Cooper's Worm (Cooperia oncophora), Bankrupt Worm (Trichostrongylus colubriformis), Nodular Worm (Oesophagostomum columbianum), Large-mouth Bowel Worm (Chabertia ovina) | |
| Adult Stages of Intestinal Worms | Hookworm (Bunostomum phlebotomum), Bankrupt Worm (Trichostrongylus colubriformis), Nodular Worm (Oesophagostomum radiatum) | ||
| Adult and 4th Stage Larvae of Lungworms | Dictyocaulus viviparus | ||
| Adult and Larval Stages of Lungworms | Dictyocaulus filaria |
Dosage And Administration
Valbazen Suspension should be administered to cattle and goats at the recommended rate of 4 mL/100 lb of body weight (equivalent to 4.54 mg of albendazole/lb, 10 mg/kg) and to sheep at the recommended rate of 0.75 mL/25 lb of body weight (equivalent to 3.4 mg of albendazole/lb, 7.5 mg/kg). The following table indicates recommended dosing schedules. Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.
| Cattle | Sheep | Goats | |||
|---|---|---|---|---|---|
| Body Weight | Dosage | Body Weight | Dosage | Body Weight | Dosage |
| 250 lb | 10 mL | 25 lb | 0.75 mL | 25 lb | 1 mL |
| 500 lb | 20 mL | 50 lb | 1.5 mL | 50 lb | 2 mL |
| 750 lb | 30 mL | 75 lb | 2.25 mL | 75 lb | 3 mL |
| 1000 lb | 40 mL | 100 lb | 3.0 mL | 100 lb | 4 mL |
| 1250 lb | 50 mL | 200 lb | 6.0 mL | 125 lb | 5 mL |
| 1500 lb | 60 mL | 300 lb | 9.0 mL | 150 lb | 6 mL |
Cattle: 1 liter of Valbazen 11.36% Suspension will treat 50 animals weighing 500 lb.
Sheep: 1 liter of Valbazen 11.36% Suspension will treat 664 animals weighing 50 lb.
Goats: 1 liter of Valbazen 11.36% Suspension will treat 500 animals weighing 50 lb.
Valbazen 11.36% Suspension should be given orally using any type of standard dosing gun or dose syringe.
Important
Accurate estimates of the weight of the cattle, sheep, and goats to be treated are essential for most effective results with this product. Animals constantly exposed to internal parasites should be retreated as necessary.
Residue Warnings
Cattle must not be slaughtered within 27 days following last treatment. Sheep and Goats must not be slaughtered within 7 days following last treatment. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. Do not use in lactating does.
Other Warnings
Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance. Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd/flock, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). A decrease in a drug’s effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.
Precaution
Do not administer to female cattle during first 45 days of pregnancy or for 45 days after removal of bulls. Do not administer to ewes or does during the first 30 days of pregnancy or for 30 days after removal of rams or bucks. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
Principal Display Panel - 1 L/33.8 Fl Oz Bottle Label
VALBAZEN®
(albendazole)
Broad-Spectrum Dewormer
Oral Suspension for Use in Cattle, Sheep, and Goats
for removal and control of liver flukes, tapeworms,
stomach worms (including 4th stage inhibited
larvae of Ostertagia ostertagi), intestinal worms,
and lungworms in cattle and sheep and for the
treatment of adult liver flukes in nonlactating goats
Active Ingredient
Albendazole
(equivalent to 113.6 mg/mL)
11.36%
1 L/33.8 fl oz (1 qt 1.8 fl oz)
NADA #110-048, Approved by FDA
8784000
13945100
zoetis
Principal Display Panel - 5 L/169 Fl Oz Bottle Label
VALBAZEN®
(albendazole)
Broad-Spectrum Dewormer
Oral Suspension for Use in Cattle, Sheep, and Goats
for removal and control of liver flukes, tapeworms,
stomach worms (including 4th stage inhibited
larvae of Ostertagia ostertagi), intestinal worms,
and lungworms in cattle and sheep and for the
treatment of adult liver flukes in nonlactating goats
Active Ingredient
Albendazole
(equivalent to 113.6 mg/mL)
11.36%
5 L/169 fl oz (1 gal 1 qt 9 fl oz)
NADA #110-048, Approved by FDA
8785000
13945600
zoetis
Principal Display Panel - 500 Ml/16.9 Fl Oz Bottle Label
VALBAZEN®
(albendazole)
Broad-Spectrum Dewormer
Oral Suspension for Use in Cattle, Sheep, and Goats
for removal and control of liver flukes, tapeworms,
stomach worms (including 4th stage inhibited larvae of
Ostertagia ostertagi), intestinal worms, and lungworms
in cattle and sheep and for the treatment of adult liver
flukes in nonlactating goats
Active Ingredient:
Albendazole
(Equivalent to 113.6 mg/mL)
11.36%
500 mL/16.9 fl oz (1 pt 1 fl oz)
NADA #110-048, Approved by FDA
zoetis
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.