Animal NDC 57319-509-61 Phenylbute
Phenylbutazone

Animal Product Information

Field Name Field Value
Animal NDC Code 57319-509-61
Proprietary Name Phenylbute 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 Phenylbutazone 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 Clipper Distributing Company Llc
Product Type Prescription Animal Drug
Usage Information
    Phenylbutazone is for the relief of inflammatory conditions associated with the musculoskeletal system in horses. In the treatment of inflammatory conditions associated with infections, specific anti-infective therapy should be used concurrently.
Active Ingredient(s)
  • Phenylbutazone
Marketing Category ANADA - ABBREVIATED 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 ANADA200334 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.

Phenylbute Images

Phenylbute 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



For Oral Use In Horses Only

NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID)

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this product in female dairy cattle 20 months of age or older.


Description



Phenylbutazone chemically is 4-butyl-1,2-diphenyl-3,5-pyrazolidinedione. 

C19H20N2O2

Mol. Wt. 308.38

Each 10 grams of powder contains 1 gram phenylbutazone


Indications



Phenylbutazone is for the relief of inflammatory conditions associated with the musculoskeletal system in horses. In the treatment of inflammatory conditions associated with infections, specific anti-infective therapy should be used concurrently.


Dosage And Administration



For Horses Only: Administer orally (using the 0.6  ounce (18 mL) scoop provided) on a small amount of palatable feed and mix well. Give 1 to 2 level scoops per 500 pounds of body weight, but do not exceed 4 scoops per animal daily. Use the high dose for the first 48 hours, then gradually reduce to a maintenance dose.


Contraindications



Use with caution in patients who have a history of drug allergy.


Warning



Do not use in horses intended for human consumption.


Human Warning



Keep this and all medications out of the reach of children. Dispense in tight, child resistant containers.


Precaution



Concomitant use with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided or closely monitored.


Clinical Pharmacology



Phenylbutazone was first synthesized in 1948 and introduced into human medicine in 1949. Kuzell (1), (2), (3), Payne (4), Fleming (5) and Denko (6) demonstrated the clinical effectiveness of phenylbutazone in gout, gouty arthritis, acute arthritis, acute rheumatism and various other rheumatoid disorders in humans. Fabre (7), Domenjoz (8), Wilhelmi (9) and Yourish (10) have established the anti-rheumatic and anti-inflammatory activity of phenylbutazone. It is entirely unrelated to the steroid hormones.
Toxicity of phenylbutazone has been investigated in rats and mice (11) and dogs (12).
Phenylbutazone has been used by Camberos (13) in thoroughbred horses. Favorable results were reported in cases of traumatism, muscle rupture, strains and inflammations of the third phalanx. Results were not as favorable in the period treatment of osteoarthritis of the stifle and hip, arthrosis of the trapezious muscles and general arthritis. Sutter (14) reported a favorable response in chronic equine arthritis of long duration, fair results in severely bruised mare and poor results in two cases where the condition was limited to the third phalanx.


How Supplied



Phenylbutazone Powder is supplied in 1.1 lb (0.5 kg) jars and 2.2 lb (1 kg) jars each containing a dispensing scoop. One level scoop delivers 10 grams of powder containing 1 gram of phenylbutazone.


References



1. Kuzell, WC, Schaffarzick, RW, Naughler, WE, Gandia, C, and Mankle, EA: A.M.A. Arch. Inst. Med., 92:646 (1953).
2. Kuzell, WC, Schaffarzick, RW, Brown, B, and Mankle, EA: J.A.M.A., 149:729 (1952).
3. Kuzell, WC, and Schaffarzick, RW: Calif. Med., 77:319 (1952).
4. Payne, RW, Shelter, MR, Farr, CH, Hellbaum, AA, and Ishmall, WK: J. Lab. Clin. Med., 45:331 (1955).
5. Fleming, J, and Will, G: Ann. Rheumat., Dis., 12:95 (1953).
6. Denko, CW, and Rumi, D: American Pract., 6:1865 (1955).
7. Fabre, J, et al: Semain. Hop. (Paris), 31:87 (1955).
8. Domenjoz, R, et al: Arzneimittel-Forsch, 5:488 (1955).
9. Wilhelmi, G, and Pulver, R: Arzneimittel-Forsch, 5:221 (1955).
10. Yourish, W, Paton, B, Brodie, B, and Burns, J: A.M.A. Arch. Ophth., 53:264 (1955).
11. Hazelton, LW, Tusing, TW, and Hollana, EG: J. Pharmacol. Exper. Ther., 109:387 (1953).
12. Ogilvie, FB, and Sutter, MD: Vet. Med. 52:492 (1957).
13. Camberos, HR: Rev. Med. Vet. (Buenos Aries), 38:9 (1956).
14. Sutter, MD: Vet. Med., 53:83 (1958).


Principal Display Panel - Phenylbute Powder (1.1 Lb Jar)



​NDC 57319-509-62

Phenylbute® Powder

(Phenylbutazone Powder)

For Oral Use In Horses Only

NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID)

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this product in female dairy cattle 20 months of age or older.

Net Contents: 1.1 lb (0.5 kg)

Approved by FDA under ANADA # 200-334


Principal Display Panel - Phenylbute Powder (2.2 Lb Jar)



NDC 57319-509-61

Phenylbute® Powder

(Phenylbutazone Powder)

For Oral Use In Horses Only

NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID)

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this product in female dairy cattle 20 months of age or older.

Net Contents: 2.2 lb (1 kg)

Approved by FDA under ANADA # 200-334


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