Animal NDC 86108-946-01 Ampicillin
Animal Product Information
|Field Name||Field Value|
|Animal NDC Code||86108-946-01|
|Proprietary Name||Ampicillin 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||Ampicillin 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||Us Vet Inc|
|Product Type||Prescription Animal Drug|
|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||ANADA200180 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.
Ampicillin 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
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Ampicillin for injectable suspension is a broad-spectrum penicillin which has bactericidal activity against a wide range of common gram-positive and gram-negative bacteria.
Each 25 g vial contains: 25 g ampicillin activity as ampicillin trihydrate, 90 mg methylparaben (as preservative), 10 mg propylparaben (as preservative), 200 mg lecithin, 500 mg povidone, 200 mg sodium chloride, 600 mg sodium citrate anhydrous.
Ampicillin for injectable suspension has proved effective in the treatment of many infections previously beyond the spectrum of penicillin therapy. This drug is particularly indicated in the treatment of the following infections caused by susceptible strains of organisms:
Dogs and Cats - Respiratory Tract Infections: Upper respiratory infections, tonsillitis and bronchopneumonia due to hemolytic streptococci, Staphylococcus aureus, Escherichia coli, Proteus mirabilis and Pasteurella spp.
Urinary Tract Infections due to Proteus mirabilis, Escherichia coli, Staphylococcus spp., hemolytic streptococci and Enterococcus spp.
Gastrointestinal Infections due to Enterococcus spp., Staphylococcus spp. and Escherichia coli.
Skin, Soft Tissue and Post-Surgical Infections: Abscesses, pustular dermatitis, cellulitis and infections of the anal gland, due to Escherichia coli, Proteus mirabilis, hemolytic streptococci, Staphylococcus spp. and Pasteurella spp.
Cattle and Calves Including Non-Ruminating (Veal Calves) - Respiratory Tract Infections: Bacterial pneumonia (shipping fever, calf pneumonia and bovine pneumonia) caused by Aerobacter spp., Klebsiella spp., Staphylococcus spp., Streptococcus spp., Pasteurella multocida and E. coli susceptible to ampicillin trihydrate.
The dosage of ampicillin for injectable suspension will vary according to the animal being treated, the severity of the infection and the animal’s response.
Dogs and Cats - The recommended dose for dogs or cats is 3 mg/lb of body weight administered twice daily by subcutaneous or intramuscular injection.
Cattle and Calves Including Non-Ruminating (Veal Calves) - From 2 mg to 5 mg/lb of body weight once daily by intramuscular injection. Do not treat for more than 7 days.
In all species, 3 days treatment is usually adequate, but treatment should be continued for 48 to 72 hours after the animal has become afebrile or asymptomatic.
Directions For Use:
The multi-dose dry-filled vials should be reconstituted to the desired concentration by adding the required amount of Sterile Water for Injection, USP, according to label directions. SHAKE WELL.
After reconstitution this product is stable for 3 months under refrigeration and will be white to pale yellow in color.
At the time of reconstitution the vial should be dated and the concentration noted on the label.
A history of allergic reactions to penicillin, cephalosporins or their analogues should be considered a contraindication for the use of this agent.
DO NOT TREAT CATTLE FOR MORE THAN 7 DAYS.
MILK FROM TREATED COWS MUST NOT BE USED FOR FOOD DURING TREATMENT, AND FOR 48 HOURS (4 MILKINGS) AFTER THE LAST TREATMENT.
CATTLE MUST NOT BE SLAUGHTERED FOR FOOD DURING TREATMENT, AND FOR 144 HOURS (6 DAYS) AFTER THE LAST TREATMENT.
Because it is a derivative of 6-aminopenicillanic acid, ampicillin for injectable suspension has the potential for producing allergic reactions. If they should occur, ampicillin for injectable suspension should be discontinued and the subject treated with the usual agents (antihistamines, pressor amines, corticosteroids).
The antimicrobial action of ampicillin is bactericidal, and only a small percentage of the antibiotic is serum-bound. Peak serum levels in dogs and cats are reached approximately one-half hour following subcutaneous or intramuscular injection, and in cattle 1 hour to 2 hours following intramuscular injection.
In vitro studies have demonstrated sensitivity of the following organisms to ampicillin: gram-positive bacteria - alpha- and beta-hemolytic streptococci, staphylococci (non-penicillinase-producing), Bacillus anthracis and most strains of enterococci and clostridia; gram-negative bacteria - Proteus mirabilis, E. coli and many strains of Salmonella and Pasteurella multocida.
The drug does not resist destruction by penicillinase and, hence, is not effective against strains of staphylococci resistant to penicillin G. Susceptibility tests should be conducted to estimate the in vitro susceptibility of bacterial isolates to ampicillin.
Store at or below 25°C (77°F) with excursions permitted up to 30°C (86°F). After reconstitution, store under refrigeration.
Ampicillin for injectable suspension is supplied in vials containing 25 grams ampicillin activity as ampicillin trihydrate.
Package/Label Principal Display Panel
NDC 86108-946-01 Ampicillin for Injectable Suspension For Veterinary Use only Caution: Federal Law restricts this drug to use by or on the order of a licensed veterinarian. Equivalent to 25 g Ampicillin. Approved by FDA under ANADA # 200-180
Each vial contains: 25 g ampicillin activity as ampicillin trihydrate, 90 mg methylparaben (as preservative), 10 mg propylparaben (as preservative), 200 mg lecithin, 500 mg povidone, 200 mg sodium chloride, 600 mg sodium citrate anhydrous.
After reconstitution, this product is stable for 3 months under refrigeration. SHAKE WELL. Date Reconstituted__________ / ________mg/mL READ INNER PANEL. Dosage: Dogs and Cats - 3 mg/lb of body weight twice daily by subcutaneous or intramuscular injection. Cattle and Calves Including Non-Ruminating (Veal Calves) - From 2 mg to 5 mg/lb of body weight once daily by intramuscular injection. Do not treat for more than 7 days. See inner panel for additional dosage recommendations. Residue Warnings: Do not treat cattle for more than 7 days. Milk from treated cows must not be used for food during treatment, and for 48 hours (4 milkings) after the last treatment. Cattle must not be slaughtered for food during treatment, and for 144 hours (6 days) after the last treatment. Store at or below 25°C (77°F) with excursions permitted up to 30°C (86°F). After reconstitution, store under refrigeration.
US Vet Inc. Hamilton, NY 13346 Rev. 12/2019 LBL16155 03
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