Terramycin 200 for Fish

Manufacturer
Phibro Animal Health | Phibro Animal Heatlh
Effective date
2023-11-06
Label type
VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:42:26

Label at a glance#

ProductTerramycin 200 for Fish
Active ingredientOXYTETRACYCLINE HYDROCHLORIDE
Label structure7 sections

Dosage and administration

Note that feeding rates may vary depending on the size and health of the fish. Feeding rates should be chosen to ensure that all fish in the rearing unit are adequately medicated. Use the table below to calculate the amount of Terramycin 200 for Fish to use at your feeding rate. Feeding Rate* To achieve a dose rate of 2.5 – 3.75 g/100 pounds of fish pounds/100 pounds (%) Terramycin concentration Type C Medicated F...

Storage and handling

SEE BACK PANEL FOR COMPLETE MIXING AND USE DIRECTIONS, AND WARNINGS Terramycin is a registered trademark of Pfizer, Inc., licensed to Phibro Animal Health Corporation, for Oxytetracycline. PHIBRO and PHIBRO logo design are trademarks owned by Phibro Animal Health Corporation or its affiliates Phibro Animal Health Corporation, Teaneck, NJ 07666 Net Weight 50 lb (22.6 kg) Approved by FDA under NADA #038-439 7938000 ...

Label contents#

Full prescribing information#

Active Drug Ingredient:

DESCRIPTION SECTION

Oxytetracycline (from oxytetracycline dihydrate) equivalent to

oxytetracycline hydrochloride (Terramycin®) . . . . . . . . . . . . . . . . . . . . . 200 g/lb

CAUTION:

WARNINGS AND PRECAUTIONS SECTION

CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

CAUTION: For use in manufacturing medicated fish and lobster feeds only. For use in dry feeds only. Not for use in liquid feed supplements.

CAUTION: Certain components of animal feeds, including medicated premixes, possess properties that may be a potential health hazard or a source of personal discomfort to certain individuals who are exposed to them. Human exposure should, therefore, be minimized by observing the general industry standards for occupational health and safety.

Precautions such as the following should be considered: dust masks or respirators and protective clothing should be worn; dust-arresting equipment and adequate ventilation should be utilized; personal hygiene should be observed; wash before eating or leaving a work site; be alert for signs of allergic reactions—seek prompt medical treatment if such reactions are suspected.

STORE AT ROOM TEMPERATURE

STORAGE AND HANDLING SECTION

SEE BACK PANEL FOR COMPLETE MIXING AND USE DIRECTIONS, AND WARNINGS

Terramycin is a registered trademark of Pfizer, Inc.,

licensed to Phibro Animal Health Corporation, for Oxytetracycline.

PHIBRO and PHIBRO logo design are trademarks owned by

Phibro Animal Health Corporation or its affiliates

Phibro Animal Health Corporation, Teaneck, NJ 07666

Net Weight 50 lb (22.6 kg)

Approved by FDA under NADA #038-439

7938000

101-9090-09

DOSAGE & ADMINISTRATION SECTION

SPECIES

INDICATIONS FOR USE

FEEDING DIRECTIONS

SALMONIDS

For control of ulcer disease caused by Hemophilus piscium, furunculosis caused by Aeromonas salmonicida, bacterial hemorrhagic septicemia caused by Aeromonas liquefaciens and pseudomonas disease.

Administer medicated feed to provide a dosage of 2.5 - 3.75 g of oxytetracycline per 100 lb of fish daily for 10 days (see finfish mixing directions below). If mortality is not reduced by the fifth day

of treatment, the diagnosis should be reexamined.

Warning: Do not liberate or slaughter salmonids for food during treatment or for 21 days following last feeding of medicated feed.

PACIFIC SALMON

WEIGHING UP TO 30 GRAMS

For marking of skeletal tissue.

Administer medicated feed as the sole ration to provide a dosage of 11.35 g of oxytetracycline per 100 lb of fish (250 mg per kg of fish) daily for 4 consecutive days.

Warning: Do not liberate for at least 7 days following last feeding of medicated feed.

FRESHWATER-REARED

SALMONIDS

For the control of mortality in freshwater-reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum.

Administer medicated feed to provide a dosage of 3.75 g of oxytetracycline per 100 lb of fish daily for 10 days (see finfish mixing directions below).

Warning: Do not liberate or slaughter freshwater-reared salmonids for food during treatment or for 21 days following last feeding of medicated feed.

FRESHWATER-REARED SALMONIDS WEIGHING UP TO 55 GRAMS

For marking of skeletal tissue.

Administer medicated feed to provide a dosage of 3.75 g of oxytetracycline per 100 lb of fish daily for 10 days (see finfish mixing directions below).

Warning: Immediate release is permitted following last feeding of medicated feed.

FRESHWATER-REARED

Oncorhynchus mykiss

For the control of mortality in freshwater-reared Oncorhynchus mykiss due to columnaris disease associated with Flavobacterium columnare.

Administer medicated feed to provide a dosage of 3.75 g of oxytetracycline per 100 lb of fish daily for 10 days (see finfish mixing directions below).

Warning: Do not liberate or slaughter Oncorhynchus mykissfor food during treatment or for 21 days following last feeding of medicated feed.

CATFISH

For control of bacterial hemorrhagic septicemia caused by Aeromonas liquefaciens and pseudomonas disease.

Administer medicated feed to provide a dosage of 2.5 - 3.75 g of oxytetracycline per 100 lb of fish daily for 10 days (see finfish mixing directions below). If mortality is not reduced by the fifth day of treatment, the diagnosis should be reexamined.

Warning: Do not liberate or slaughter catfish for food during treatment or for 21 days following last feeding of medicated feed. Do not use when water temperature is below 62°F (16.7°C).

LOBSTER

For control of gaffkemia caused by Aerococcus viridans.

Administer 1 g/lb of medicated feed as sole ration for 5 consecutive days (see lobster mixing directions below).

Warning: Withdraw medicated feed 30 days before harvesting lobsters.

MIXING DIRECTIONS—Finfish

DOSAGE & ADMINISTRATION SECTION

Note that feeding rates may vary depending on the size and health of the fish. Feeding rates should be chosen to ensure that all fish in the rearing unit are adequately medicated.

Use the table below to calculate the amount of Terramycin 200 for Fish to use at your feeding rate.

Feeding Rate*

To achieve a dose rate of 2.5 – 3.75 g/100 pounds of fish

pounds/100 pounds (%)

Terramycin concentration Type C Medicated Feed

Terramycin 200 for Fish per ton of feed

Total biomass that one ton of medicated feed will treat**

1

2

3

4

5

6

7

8

9

10

15

(g/ton)

5,000 – 7,500

2,500 – 3,750

1,667 – 2,500

1,250 – 1,875

1,000 – 1,500

833 – 1,250

714 – 1071

625 – 938

556 – 833

500 – 750

333 – 500

(pounds)

25.00 – 37.50

12.50 – 18.75

8.33 – 12.50

6.25 – 9.38

5.00 – 7.50

4.17 – 6.25

3.57 – 5.36

3.13 – 4.69

2.78 – 4.17

2.50 – 3.75

1.67 – 2.50

(pounds)

200,000

100,000

66,667

50,000

40,000

33,333

28,571

25,000

22,222

20,000

13,333

* To calculate g Terramycin per ton finished feed at other feeding rates: (desired dose rate/feeding rate) x 2000

To calculate Terramycin 200 for Fish per ton at other feeding rates: g Terramycin per ton finished feed/200

Example: at a feeding rate of 2.5% (2.5 pounds per 100 pounds), with a desired dose of 3.75 g/100 pounds: 3.75 g per 100 lb/2.5 lb per 100 lb = 1.5 g per lb x 2000 lb = 3000 g Terramycin/ton

3000 g Terramycin per ton/200 g Terramycin per lb of Terramycin 200 for Fish = 15 pounds Terramycin per ton of feed

** To calculate total required medicated feed for the 10 day treatment period, multiply total estimated rearing unit biomass by 10 and divide by the pounds of medicated feed needed at your feeding rate

Example: at a feeding rate of 2% in a unit containing 5,000 pounds of fish biomass:

5,000 lb x 10 = 50,000 lb/100,000 lb per ton = 0.5 tons

MIXING DIRECTIONS—Lobsters

SPL UNCLASSIFIED SECTION

Mix 10 pounds of Terramycin 200 for Fish per ton of feed to achieve the dose rate of 1 g/lb.

INDICATIONS & USAGE SECTION

NOT FOR HUMAN USE

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED

Terramycin 200 for Fish

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Terramycin 200 for FishTerramycin 200 for FIshTerramycin 200 for FIsh

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66104-7938-0Terramycin 200 for Fish22.6 kg in 1 BAGPOWDER22.68

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66104-7938TERRAMYCIN 200 FOR FISH (OXYTETRACYCLINE QUARTENARY SALT) POWDER [PHIBRO ANIMAL HEALTH]81 package rows20231108_567d39a7-5f2e-47ae-8797-b484c500d22e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OXYTETRACYCLINE HYDROCHLORIDEACTIVE INGREDIENT4U7K4N52ZM3
OXYTETRACYCLINE ANHYDROUSACTIVE MOIETYSLF0D9077S3
RICE BRANINACTIVE INGREDIENTR60QEP13IC3
SOYBEAN OILINACTIVE INGREDIENT241ATL177A3

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66104-793866104-7938-0

Ingredients#

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

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

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 · 7 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION, EMULSION / INTRAVENOUS107100 mgExact identifier — unii candidate
7 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177ASOLUTION / TOPICAL5.82 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177ACAPSULE / ORAL1318 mgExact identifier — unii candidate
7 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS223 mgExact identifier — unii candidate
7 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AAEROSOL, FOAM / TOPICAL50 %w/wExact identifier — unii candidate
7 equally ranked IID candidates

Reported adverse events (FAERS/openFDA)#

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