1. Home
  2. Animal Drug Index - L
  3. Lincomycin-spectinomycin Water Soluble Powder

Animal NDC 23243-4240-2 Lincomycin-spectinomycin Water Soluble Powder

Lincomycin-spectinomycin

Animal Product Information

Field Name Field Value
Animal NDC Code 23243-4240-2
Proprietary Name Lincomycin-spectinomycin Water Soluble Powder 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 Lincomycin-spectinomycin 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 Huvepharma, Inc
Product Type Prescription Animal Drug
Usage Information
                                                                DIRECTIONS FOR USEINDICATIONS AND USAGE: For use in chickens up to 7 days of age as an aid in the control of:Airsacculitis caused by either Mycoplasma synoviae or Mycoplasma gallisepticum susceptible to lincomycin-spectinomycin.Complicated Chronic Respiratory Disease (Air Sac Infection) caused by Escherichia coli and M. gallisepticum susceptibleto lincomycin-spectinomycin.
Active Ingredient(s)
  • Spectinomycin Hydrochloride
  • Lincomycin Hydrochloride
Inactive Ingredient(s)
  • SUCROSE (C151H8M554)
  • SUCROSE (C151H8M554)
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 ANADA200407 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.

Lincomycin-spectinomycin Water Soluble Powder Images

Lincomycin-spectinomycin Water Soluble Powder 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



Other



LINCOMYCIN-SPECTINOMYCIN

WATER SOLUBLE POWDER
Antibacterial and Antimycoplasmal

Manufactured For:
Huvepharma, Inc. Peachtree City, GA 30269

® Registered Trademark of Huvepharma, Inc.


General Precautions



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

FOR USE IN CHICKENS ONLY

PRECAUTION: Discard medicated drinking water daily and replace with fresh medicated drinking water.


Dosage & Administration



This packet contains:
Lincomycin hydrochloride, equivalent to lincomycin ...... 16.7 grams
Spectinomycin dihydrochloride pentahydrate,
                        equivalent to spectinomycin.................33.3 grams
  Total Antibiotic Activity             50.0 grams

Approved by FDA under ANADA # 200-407
NET WEIGHT: 2.65 oz (75 grams)

® Registered Trademark of Huvepharma, Inc

DOSAGE AND ADMINISTRATION
Dosage: Provide 2 grams (g) antibiotic activity per gallon of drinking water. Administer as the sole source of water for the first 5 to 7 days of life.

Administration:

Amount of Lincomycin-Spectinomycin Amount of Drinking Water
 1 packet 25 gallons
For proportioners delivering 1 ounce of solution per gallon of drinking water,
dissolve contents of 5 packets in each gallon of proportioner solution.

IMPORTANT: Chickens should consume water at the following approximate rate to ensure intake of the required dose of lincomycin-spectinomycin indicated:

 Broilers and Layer Replacements (Light and Heavy)
 Age
(Weeks)		 Daily Water Intake
(Gallons/1000)		 Dosage
(mg Antibiotic/lb)
 1 5 50-65


Indications & Usage



                                                            DIRECTIONS FOR USE
INDICATIONS AND USAGE: For use in chickens up to 7 days of age as an aid in the control of:
Airsacculitis caused by either Mycoplasma synoviae or Mycoplasma gallisepticum susceptible to lincomycin-spectinomycin.

Complicated Chronic Respiratory Disease (Air Sac Infection) caused by Escherichia coli and M. gallisepticum susceptible
to lincomycin-spectinomycin.


User Safety Warnings



WARNING:    Not for Human Use
                     Keep Out of Reach of Children

To report suspected adverse drug events, for technical assistance or to obtain a
copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883
or www.huvepharma.us. For additional information about adverse drug
experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or
http://www.fda.gov/reportanimalae.


Storage And Handling



Restricted Drug (California) - Use Only as Directed
Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F)


Package Label.Principal Display Panel




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