Ampicillin Sodium

Manufacturer
US Vet Inc | GC Hanford Manufacturing Company
Effective date
2024-03-06
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:42:53

Label at a glance#

ProductAmpicillin Sodium
Active ingredientAMPICILLIN SODIUM
Label structure11 sections

Dosage and administration

HORSES - The recommended dose is 3 mg per pound of body weight administered twice a day. Ampicillin sodium may be administered by either the intravenous or intramuscular route. Treatment should be continued 48 hours after all symptoms have subsided. If no response is seen in 4-5 days, diagnosis should be re-evaluated.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Ampicillin sodium is a semisynthetic penicillin with a broad spectrum of activity. Ampicillin is derived from the penicillin nucleus, 6-aminopenicillanic acid (6 APA). Chemically it is D(-)α-aminobenzyl penicillin sodium salt.

ACTION

SPL UNCLASSIFIED SECTION

Ampicillin sodium provides bactericidal activity against a wide range of common Gram-positive and Gram-negative pathogens. Ampicillin’s activity occurs during the stage of active multiplication of the pathogen and acts through inhibition of biosynthesis of cell wall mucopeptide. In vivo studies have demonstrated the susceptibility of many strains of the following Gram-positive bacteria: Staphylococcus spp. and Streptococcus spp. (including S. equi). In vivo studies have also demonstrated the susceptibility of many strains of the following Gram-negative bacteria: E. coli and Proteus mirabilis. Because it does not resist destruction by penicillinase, it is not effective against penicillinase-producing bacteria, particularly resistant staphylococci. Most strains of Pseudomonas, Klebsiella and Aerobacter are resistant.

Ampicillin sodium diffuses readily into all body tissues and fluids, with the exception of brain and spinal fluid except when the meninges are inflamed. It produces high and persistent blood levels. Most of the ampicillin is excreted unchanged in the urine.

INDICATIONS

SPL UNCLASSIFIED SECTION

Ampicillin sodium is indicated in the treatment of susceptible strains of the organisms causing the following infections in the horse: Respiratory tract infections (pneumonia and strangles) due to Staphylococcus spp., Streptococcus spp. (including S. equi), E. coli, and Proteus mirabilis.

Skin and soft tissue infections (abscesses and wounds) due to Staphylococcus spp., Streptococcus spp., E. coli, and Proteus mirabilis.

As with all antibiotics, appropriate in vitroculturing and susceptibility testing of samples taken before treatment should be conducted.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

The use of this drug is contraindicated in animals with a history of an allergic reaction to penicillin.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Ampicillin is a semisynthetic penicillin and has the potential for producing allergic reactions. If an allergic reaction occurs, administer epinephrine and/or steroids. Possible minor irritation at the injection site may occur.

WARNINGS

WARNINGS SECTION

Restricted Drug (California) - Use only as Directed.

Do not use in horses intended for human consumption.

Not for human use.

CAUTION

SPL UNCLASSIFIED SECTION

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

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

HORSES - The recommended dose is 3 mg per pound of body weight administered twice a day. Ampicillin sodium may be administered by either the intravenous or intramuscular route. Treatment should be continued 48 hours after all symptoms have subsided. If no response is seen in 4-5 days, diagnosis should be re-evaluated.

DIRECTIONS FOR USE

SPL UNCLASSIFIED SECTION

The dry filled vials should be reconstituted immediately before use by the addition of the appropriate amount of Sterile Water for Injection, USP indicated below. This results in a final concentration of approximately 300 mg per mL.

Vial Size

Amount of Diluent to be Added

1 Gram

2.6 mL

3 Gram

7.6 mL

Stability studies with the concentrated product (300 mg/mL) demonstrated that ampicillin is stable for 1 hour at room temperature (70°F - 75°F).

HOW SUPPLIED

HOW SUPPLIED SECTION

Ampicillin Sodium is supplied in vials containing 1 gram and 3 grams of ampicillin activity.

Store dry powder at room temperature, 15°C to 30°C (59°F to 86°F).

NDC 86108-335-01                   1 gm vial
NDC 86108-335-03                   3 gm vial

Approved by FDA under ANADA # 200-335

Manufactured for:
US VET Inc.
Liverpool, NY 13088

INS16425 01           Rev. 02/2024

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ampicillin Sodium for Horses vial label image
Ampicillin Sodium for Horses vial label image

NDC 86108-335-01

AMPICILLIN SODIUM

For Intravenous or Intramuscular Use in Horses Only

1 GRAM

Each vial contains: Ampicillin sodium equivalent to 1 gram ampicillin.

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

Mfd. For: US VET Inc. Liverpool, NY 13088

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1721475ampicillin 1 GM InjectionPSN2
1721475ampicillin 1000 MG InjectionSCD2
1721475ampicillin (as ampicillin sodium) 1 GM InjectionSY2
1721475ampicillin 1 GM InjectionSY2

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
4fe9b92f-7dcd-4058-8def-e75f4dcd5ab3Product name220160201
c9385d77-2af7-47a4-bc97-1127e71caf9bProduct name320160201
05b6b9ae-4ba4-27ee-4c8c-f72b41de3815Product name520151207
b353113e-7b3d-4b1f-a286-b96a3a5eac85Product name320151026
8c59be9b-72b0-49e8-b7ef-1a80c10599deProduct name320150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86108-335-01Ampicillin Sodium1 in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION12
86108-335-01Ampicillin Sodium10 in 1 TRAYINJECTION, POWDER, FOR SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86108-335AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION [US VET INC]22 package rows20240308_fac3ab93-0cf8-4959-9957-5fb5789fec53.zip

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86108-33586108-335-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
AMPICILLIN SODIUMJFN36L5S8KACTIM

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 · 22 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
generic name: AMPICILLIN SODIUM
Ampicillin SodiumAMPICILLIN SODIUMSagent Pharmaceuticals5b3796dd-6f81-4999-ae2b-a13a727957292026-07-27Warnings, Adverse reactionsName fallback
brand name: Ampicillin Sodium
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMNorthStar Rx, LLC3b683547-48ac-48ca-8fd4-6866fd17be342026-06-15Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AMPICILLINAMPICILLIN SODIUMHenry Schein, Inc.06ca924c-5f3a-4924-90f4-5ba623daaa0e2026-04-30Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
Ampicillin sodiumAMPICILLIN SODIUMMedical Purchasing Solutions, LLC402e7cc7-5ae8-c113-e063-6394a90aa54a2025-10-02Warnings, Adverse reactionsName fallback
brand name: Ampicillin sodium
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMEugia US LLCb7bf2897-8272-4c7d-84e9-6fbba0ea63fa2025-08-14Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMEugia US LLC66146d45-0fe4-46b9-b2b1-b67c219088b72025-08-14Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLINArmas Pharmaceuticals Inc.34e95c91-3767-493c-8716-38e61e7c66742025-07-31Warnings, Adverse reactionsName fallback
brand name: Ampicillin sodium
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMProPharma Distribution364b1db9-e523-7bae-e063-6294a90a651d2025-07-18Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
Ampicillin sodiumAMPICILLINCivica, Inc.2fd0f9fa-5b86-42f7-9a9f-767123638d392025-06-30Warnings, Adverse reactionsName fallback
brand name: Ampicillin sodium
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMSandoz Inc67dd2930-8482-4da5-b663-b751aff18c612025-05-16Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMSandoz Inc64a04e8c-8f78-46b3-8f45-56ef225a4f742025-02-21Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMAvenacy Inc.19546563-50b7-4160-8cbe-f8e7079cba692025-02-01Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMSandoz Incc2908a44-1da4-4885-ae5a-23f69189d91a2024-10-31Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMSandoz Incb371e1a5-1fef-4df2-8940-c4fc02b9e2f02024-10-31Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMSandoz Inc5308ddfa-4a5b-4f7b-83ce-9d1b528e050d2024-05-09Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMSandoz Inc6632a5bd-45f1-422f-80b0-46e5a628969a2024-05-08Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMSandoz Incf77db491-31c4-4a7c-a114-0f3244c970902024-05-07Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMNorthStar Rx, LLC6772d650-9814-49e4-a4ec-0b1a97b837d12024-02-22Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMMedical Purchasing Solutions, LLC690f1986-6da9-4787-e053-2a91aa0a26442023-05-23Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM

Reported adverse events (FAERS/openFDA)#

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