Animal NDC 10515-335-01 Ampicillin Sodium

Ampicillin Sodium

Animal NDC Product Code 10515-335-01

Field Name Field Value
Animal NDC Code 10515-335-01
Proprietary Name Ampicillin Sodium 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 Sodium 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 Gc Hanford Manufacturing Company
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Ampicillin Sodium
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 ANADA200335 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 Sodium Animal Product Label Images

Ampicillin Sodium 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.

Product Labeling Index

Description

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

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

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

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

Adverse Reactions

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

Restricted Drug (California) - Use only as Directed.Do not use in horses intended for human consumption.Not for human use.

Caution

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

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.

Directions For Use

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 SizeAmount of Diluent to be Added1 Gram2.6 mL3 Gram7.6 mLStability studies with the concentrated product (300 mg/mL) demonstrated that ampicillin is stable for 1 hour at room temperature (70° - 75° F).

How Supplied

Ampicillin Sodium is supplied in vials containing 1 gram and 3 grams of ampicillin activity.Store dry powder at room temperature, 15° to 30°C (59° to 86°F).NDC 10515-335-01                   1 gm vialNDC 10515-335-03                   3 gm vialANADA 200-335       Approved by FDAManufactured by:G.C. Hanford Mfg. Co.Syracuse, NY 13201                   INS15793 03           7/2011

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

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