AMPICILLIN FOR INJECTABLE SUSPENSION, Veterinary

Manufacturer
US Vet Inc | GC Hanford Manufacturing Company
Effective date
2025-03-14
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:44:26

Label at a glance#

ProductAmpicillin
Active ingredientAMPICILLIN TRIHYDRATE
Label structure13 sections

Dosage and administration

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.

Storage and handling

Store at or below 25ºC (77ºF) with excursions permitted up to 30ºC (86ºF). After reconstitution, store under refrigeration.

Label contents#

Full prescribing information#

CAUTION:

SPL UNCLASSIFIED SECTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION:

DESCRIPTION SECTION

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.

INDICATIONS:

INDICATIONS & USAGE SECTION

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.

DOSAGE:

DOSAGE & ADMINISTRATION SECTION

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:

INSTRUCTIONS FOR USE SECTION

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.

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

A history of allergic reactions to penicillin, cephalosporins or their analogues should be considered a contraindication for the use of this agent.

RESIDUE WARNINGS

WARNINGS SECTION

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.

PRECAUTIONS:

PRECAUTIONS SECTION

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).

CLINICAL PHARMACOLOGY:

CLINICAL PHARMACOLOGY SECTION

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.

STORAGE:

STORAGE AND HANDLING SECTION

Store at or below 25ºC (77ºF) with excursions permitted up to 30ºC (86ºF). After reconstitution, store under refrigeration.

HOW SUPPLIED:

HOW SUPPLIED SECTION

Ampicillin for injectable suspension is supplied in vials containing 25 grams ampicillin activity as ampicillin trihydrate.

  • NDC 86108-946-01 25 g per vial

 

SPL UNCLASSIFIED SECTION

Manufactured for:

US Vet Inc. Liverpool, NY 13088

Rev. 10/2024

LBL16155 05

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ampi Tri Label
Ampi Tri Label

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 25ºC (77ºF) with excursions permitted up to 30ºC (86ºF). After reconstitution, store under refrigeration.

Manufactured for:

US Vet Inc. Liverpool, NY 13088 Rev. 10/2024 LBL16155 05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1666111ampicillin 400 MG/ML Injectable SuspensionPSN3
1666111ampicillin 400 MG/ML Injectable SuspensionSCD3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
AMPICILLIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9d6ee0-43ae-43c7-aa52-3d5a936186d6Product name120250722
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
4fe9b92f-7dcd-4058-8def-e75f4dcd5ab3Product name220160201
c9385d77-2af7-47a4-bc97-1127e71caf9bProduct name320160201
05b6b9ae-4ba4-27ee-4c8c-f72b41de3815Product name520151207
b353113e-7b3d-4b1f-a286-b96a3a5eac85Product name320151026
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
8c59be9b-72b0-49e8-b7ef-1a80c10599deProduct name320150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
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c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86108-946-01Ampicillin1 in 1 VIAL, GLASSINJECTION, POWDER, FOR SUSPENSIO13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86108-946AMPICILLIN INJECTION, POWDER, FOR SUSPENSION [US VET INC]31 package rows20250316_18853081-6541-46f2-b2af-5d98648eaed7.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86108-94686108-946-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMPICILLINAMPICILLIN SODIUMHenry Schein, Inc.78988f6a-a73b-4d3b-9a76-d61a748c3c162026-07-31Warnings, Adverse reactionsName fallback
brand name: AMPICILLIN
AmpicillinAMPICILLINREMEDYREPACK INC.4134cd79-c895-4e6e-b1d5-8e01c38bf2d12026-07-27Warnings, Adverse reactionsName fallback
brand name: Ampicillin
ampicillinAMPICILLINSagent Pharmaceuticals9d2aebe8-4f04-49dd-b1e5-80b962868dc32026-07-27Warnings, Adverse reactionsName fallback
brand name: ampicillin
AmpicillinAMPICILLINWG Critical Care, LLC12b6ac82-ca74-4f88-99ea-ae4a1c419b702026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ampicillin
AmpicillinAMPICILLINWG Critical Care, LLC38ec7b7a-9caf-45f2-88a1-0f78f089a1e42026-06-22Warnings, Adverse reactionsName fallback
brand name: Ampicillin
AmpicillinAMPICILLIN SODIUMNorthStar Rx, LLC3b683547-48ac-48ca-8fd4-6866fd17be342026-06-15Warnings, Adverse reactionsName fallback
brand name: Ampicillin
AmpicillinAMPICILLINONESOURCE SPECIALTY PHARMA LIMITED519f3ba6-606f-bfc4-e063-6294a90af8842026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ampicillin
AMPICILLINAMPICILLIN SODIUMHenry Schein, Inc.06ca924c-5f3a-4924-90f4-5ba623daaa0e2026-04-30Warnings, Adverse reactionsName fallback
brand name: AMPICILLIN
AmpicillinAMPICILLINONESOURCE SPECIALTY PHARMA LIMITED519f2131-79e7-569f-e063-6394a90a2f932026-02-27Warnings, Adverse reactionsName fallback
brand name: Ampicillin
AMPICILLINAMPICILLINCivica, Inc.a194f310-a669-4d8f-8c04-ee9ca01939b12025-12-09Warnings, Adverse reactionsName fallback
brand name: AMPICILLIN
AMPICILLINAMPICILLIN INJECTIONHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.302e6df7-37c5-4625-8a61-3e2f302addf22025-11-07Warnings, Adverse reactionsName fallback
brand name: AMPICILLIN
AmpicillinAMPICILLINArmas Pharmaceuticals Inc.65d94837-ca25-4728-932b-139d3bf4c7162025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ampicillin
AmpicillinAMPICILLIN SODIUMEugia US LLCb7bf2897-8272-4c7d-84e9-6fbba0ea63fa2025-08-14Warnings, Adverse reactionsName fallback
brand name: Ampicillin
AmpicillinAMPICILLINAurobindo Pharma Limited7f8b1ab1-73c6-4cdf-a838-7a4554c625862025-08-14Warnings, Adverse reactionsName fallback
brand name: Ampicillin
AmpicillinAMPICILLIN SODIUMEugia US LLC66146d45-0fe4-46b9-b2b1-b67c219088b72025-08-14Warnings, Adverse reactionsName fallback
brand name: Ampicillin
AmpicillinAMPICILLINArmas Pharmaceuticals Inc.34e95c91-3767-493c-8716-38e61e7c66742025-07-31Warnings, Adverse reactionsName fallback
brand name: Ampicillin
AmpicillinAMPICILLIN SODIUMProPharma Distribution364b1db9-e523-7bae-e063-6294a90a651d2025-07-18Warnings, Adverse reactionsName fallback
brand name: Ampicillin
AmpicillinAMPICILLINSandoz Inc0a66c5c3-63bf-46e3-835e-26b555ab69542025-07-17Warnings, Adverse reactionsName fallback
brand name: Ampicillin
AmpicillinAMPICILLIN SODIUMSandoz Inc67dd2930-8482-4da5-b663-b751aff18c612025-05-16Warnings, Adverse reactionsName fallback
brand name: Ampicillin
AmpicillinAMPICILLIN SODIUMSandoz Inc64a04e8c-8f78-46b3-8f45-56ef225a4f742025-02-21Warnings, Adverse reactionsName fallback
brand name: Ampicillin

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.