Animal NDC 54771-3139-9 Albadry Plus

Novobiocin Sodium And Penicillin G Procaine

Animal NDC Product Code 54771-3139-9

Field Name Field Value
Animal NDC Code 54771-3139-9
Proprietary Name Albadry Plus 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 Novobiocin Sodium And Penicillin G Procaine 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 Zoetis Inc.
Product Type Otc Animal Drug
Active Ingredient(s)
  • Penicillin G Procaine
  • Novobiocin Sodium
Inactive Ingredient(s)
  • CHLOROBUTANOL (HM4YQM8WRC)
  • CHLOROBUTANOL (HM4YQM8WRC)
Marketing Category NADA - 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 NADA055098 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.

Albadry Plus 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

Each 10 mL PLASTET® Disposable Syringe contains: Novobiocin sodium equiv. to novobiocin 400 mg Penicillin G procaine 200,000 IU Chlorobutanol anhydrous(chloral derivative—used as a preservative)in a special bland vehicle 50 mgManufactured by a non-sterilizing process.

Indications For Use

ALBADRY PLUS Suspension is indicated for the treatment, in dry cows only, of subclinical mastitis caused by susceptible strains of Staphylococcus aureus and Streptococcus agalactiae.

Warnings

  • Do not use less than 30 days prior to calving.Milk from treated cows must not be used for food during the first 72 hours after calving.Treated animals must not be slaughtered for food for 30 days following udder infusion.

Precaution

Administration of this product in any manner other than shown under DOSAGE may result in drug residues.

Dosage

Infuse one tube per quarter at start of dry period (but not less than 30 days prior to calving).Shake Well Before Using

Directions For Using The Flexi-Tube® System

  • The FLEXI-TUBE is designed to provide the choice of either insertion of the full cannula, as has traditionally been practiced, or insertion of no more than ⅛ inch of the cannula, as recommended by the National Mastitis Council.Full Insertion: Remove the blue end cap by pulling straight up as shown. Gently insert the full cannula into the teat canal; carefully infuse the product. Partial Insertion: Remove both the blue end cap and the red cannula by pushing sideways as shown. Gently insert the exposed blue tip into the teat canal; carefully infuse the product.

Administration

At the time of drying off, but not less than 30 days prior to calving, milk the udder dry. Wash the teats and udder thoroughly with warm water containing a suitable dairy antiseptic. Dry the teats and udder thoroughly. Infuse each quarter using the following procedure. Using the alcohol pads provided, scrub each teat end clean using a separate pad for each teat. Warm ALBADRY PLUS Suspension to body temperature and shake thoroughly. Choose the desired insertion length (full or partial) and insert tip into teat canal. Instill entire contents into the quarter. Massage the udder after treatment to distribute the ALBADRY PLUS Suspension throughout the quarters. Using a suitable teat dip, dip all teats following treatment.

Storage Conditions

Store at controlled room temperature 20° to 25° C (68° to 77° F).

How Supplied

ALBADRY PLUS Suspension is available in unbroken packages of 12–10 mL PLASTET Disposable Syringes with 12 individually wrapped 70% isopropyl alcohol pads and unbroken packages of 144–10 mL PLASTET Disposable Syringes with 144 individually wrapped 70% isopropyl alcohol pads.

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

Previous Code
54771-3139-2
Next Code
54771-3179-1