Flavomycin

Manufacturer
Huvepharma, Inc. | Huvepharma EOOD
Effective date
2024-05-01
Label type
OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:43:06

Label at a glance#

ProductFlavomycin
Active ingredientBAMBERMYCINS
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

FLAVOMYCIN® 4
(bambermycins Type A medicated article)

ADVERSE REACTIONS SECTION

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 www.fda.gov/reportanimalae.

VETERINARY INDICATIONS SECTION

INDICATIONS FOR USE

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

OTC - ACTIVE INGREDIENT SECTION

ACTIVE DRUG INGREDIENT

Bambermycins 4 grams per pound (8.8 grams per kilogram)

INACTIVE INGREDIENT SECTION

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 SECTION

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

USER SAFETY WARNINGS SECTION

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

VETERINARY INDICATIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bag Label ImageBag Label Image

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23243-2060-5Flavomycin22.68 kg in 1 BAGPOWDER22.688

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23243-2060FLAVOMYCIN (BAMBERMYCINS TYPE A MEDICATED ARTICLE) POWDER [HUVEPHARMA, INC.]81 package rows20240515_226e3192-984d-4ff0-9e65-c1e54a78e522.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BAMBERMYCINSACTIVE INGREDIENTPP922A42V22
BAMBERMYCINSACTIVE MOIETYPP922A42V22
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGK2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP2

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23243-206023243-2060-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
BAMBERMYCINSPP922A42V2ACTIB
MINERAL OILT5L8T28FGPIACT
CALCIUM CARBONATEH0G9379FGKIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 45 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MINERAL OILMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, COATED / ORAL64.8 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKGUM, CHEWING / BUCCAL3492 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET / ORAL793 mgExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, EXTENDED RELEASE / ORAL229.7 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE / ORAL349.9 mgExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, DELAYED RELEASE / ORAL8.4 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE, DELAYED RELEASE / ORAL20 mgExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / RESPIRATORY (INHALATION)4.02 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / INTRAVENOUS4.02 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, FILM COATED / ORAL300 mgExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / AURICULAR (OTIC)0.38 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / DENTAL95 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKFILM, SOLUBLE / ORAL14 mgExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKPOWDER, DENTIFRICE / DENTAL0.5 mg/mgExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates

Reported adverse events (FAERS/openFDA)#

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