Animal NDC 23243-2060-5 Flavomycin

Bambermycins Type A Medicated Article

Animal Product Information

Field Name Field Value
Animal NDC Code 23243-2060-5
Proprietary Name Flavomycin 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 Bambermycins Type A Medicated Article 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 Otc Type A Medicated Article Animal Drug
Usage Information
    INDICATIONS FOR USEFor increased rate of weight gain and improved feed efficiency in broiler chickens,growing-finishing swine and growing turkeys. FLAVOMYCIN® 4(bambermycins Type A Medicated Article)ANTIBIOTIC INDICATIONS FOR USESpeciesBambermycins g/ton in Type C medicated feedIndication(s)BroilerChickens1-2*Increased rate of weight gain;improved feed efficiencyGrowing-FinishingSwine2Increased rate of weight gain;improved feed efficiency2-4*Increased rate of weight gainGrowing Turkeys2Increased rate of weight gain;improved feed efficiency1-2*Improved feed efficiency*Only a single level of bambermycins (e.g., 4 grams/ton bambermycins) can be indicated on a feed tag. A different feed tag must be submitted for each level of bambermycins needed for your complete feeding program.MIXING DIRECTIONS:It is recommended that Flavomycin® 4 be diluted with a suitable grain carrier before addition to the final feed. A dilution of 1 part of Flavomycin® 4 and 9 parts grain carrier is the suggested working intermediate preblend. The table below shows Flavomycin® 4 and working intermediate preblend addition levels for various commonly used feeds:FeedBambermycins in Type C Medicated Feed (g/ton)Pounds Flavomycin® 4 per Ton Type C      Medicated Feed      Pounds 1-9                 Intermediate     Preblend per Ton       Type C Medicated       FeedBroilerChickens12.25.502.505.00Growing-FinishingSwine234.50.751.005.007.5010.00GrowingTurkeys12.25.502.505.00Thoroughly mix both working intermediate preblend and finished Type C medicated feed to ensure complete and uniform distribution of the Flavomycin® 4.FEEDING DIRECTIONS:Type C medicated feed containing Flavomycin® 4 should be fed continuously as the sole ration.Huvepharma®Approved by FDA under NADA #044-759
Active Ingredient(s)
  • Bambermycins
Inactive Ingredient(s)
  • MINERAL OIL (T5L8T28FGP)
  • CALCIUM CARBONATE (H0G9379FGK)
  • MINERAL OIL (T5L8T28FGP)
  • CALCIUM CARBONATE (H0G9379FGK)
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 NADA044759 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.

Flavomycin Images

Flavomycin 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



FLAVOMYCIN® 4
(bambermycins Type A medicated article)


Adverse Reactions



ANTIBIOTIC

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.


Veterinary Indications



INDICATIONS FOR USE

For increased rate of weight gain and improved feed efficiency in broiler chickens,
growing-finishing swine and growing turkeys.

FLAVOMYCIN® 4
(bambermycins Type A Medicated Article)

ANTIBIOTIC 

INDICATIONS FOR USE

Species

Bambermycins g/ton in

Type C medicated feed

Indication(s)

Broiler

Chickens

1-2*

Increased rate of weight gain;

improved feed efficiency

Growing-

Finishing

Swine

2

Increased rate of weight gain;

improved feed efficiency

2-4*

Increased rate of weight gain

Growing Turkeys

2

Increased rate of weight gain;

improved feed efficiency

1-2*

Improved feed efficiency

*Only a single level of bambermycins (e.g., 4 grams/ton bambermycins) can be indicated on a feed tag. A different feed tag must be submitted for each level of bambermycins needed for your complete feeding program.

MIXING DIRECTIONS:

It is recommended that Flavomycin® 4 be diluted with a suitable grain carrier before addition to the final feed. A dilution of 1 part of Flavomycin® 4 and 9 parts grain carrier is the suggested working intermediate preblend. The table below shows Flavomycin® 4 and working intermediate preblend addition levels for various commonly used feeds:

Feed

Bambermycins in Type C Medicated Feed (g/ton)

Pounds Flavomycin® 4 per Ton Type C      Medicated Feed 

     Pounds 1-9                 Intermediate

     Preblend per Ton       Type C Medicated       Feed

Broiler

Chickens

1

2

.25

.50

2.50

5.00

Growing-

Finishing

Swine

2

3

4

.50

.75

1.00

5.00

7.50

10.00

Growing

Turkeys

1

2

.25

.50

2.50

5.00

Thoroughly mix both working intermediate preblend and finished Type C medicated feed to ensure complete and uniform distribution of the Flavomycin® 4.

FEEDING DIRECTIONS:

Type C medicated feed containing Flavomycin® 4 should be fed continuously as the sole ration.

Huvepharma®

Approved by FDA under NADA #044-759


Otc - Active Ingredient



ACTIVE DRUG INGREDIENT

Bambermycins 4 grams per pound (8.8 grams per kilogram)


Inactive Ingredient



INGREDIENTS

Roughage products and/or calcium carbonate, dried bambermycins fermentation product,
ethoxyquin (a preservative), mineral oil.

MIXING DIRECTIONS AND INDICATIONS ON REVERSE SIDE


Residue Warning



WITHDRAWAL PERIODS
No withdrawal period is required when used according to labeling.


User Safety Warnings



FOR USE IN MANUFACTURED FEEDS ONLY

USER SAFETY WARNINGS
Not For Human Use
Keep out of reach of children.

Restricted Drug (California) – Use only as directed

Net Weight – 50 pounds (22.68 kg)

Distributed by:
HUVEPHARMA, INC.
Peachtree City, GA 30269


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