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Animal NDC 50378-011-10 Syncaine

Tricaine

Animal Product Information

Field Name Field Value
Animal NDC Code 50378-011-10
Proprietary Name Syncaine 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 Tricaine 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 Western Chemical Inc.
Product Type Otc Animal Drug
Active Ingredient(s)
  • Tricaine Methanesulfonate
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 ANADA200226 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.

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Syncaine 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



Warnings



WARNINGS

Do not use within 21 days of harvesting fish for food. Use in fish intended for food should be restricted to Ictaluridae, Salmonidae, Esocidae, and Percidae, and water temperature exceeding 10°C (50°F). In other fish and in cold-blooded animals, SYNCAINE should be limited to hatchery or laboratory use. Avoid inhaling or getting into eyes.


Toxicology



Comparative toxicologic studies carried out on fish and frogs gave the following results:
FISH TOXCITY STUDIES - The toxicity of SYNCAINE was measured by standard methods in laboratory bioassays with rainbow trout, brown trout, brook trout, lake trout, northern pike, channel catfish, bluegill, largemoth bass and walleye. The 24, 48 and 96 hour LC50 (lethal concentration for 50 percent of the animals) values for trout ranged from 52 to 31 mg/liter; for northern pike, from 56 to 48 mg/liter; for catfish, from 66 to 50 mg/liter; for bluegill and largemouth bass, from 61 to 39 mg/liter; and for walleye, the values were 49 to 46 mg/liter.
Safety Index:The safety indices for SYNCAINE refer to the margin between concentrations which cause anesthesia and mortality. They are expressed by the quotient of the lethal concentration for 50 percent of the fish (LC50) and the effective concentration for 50 percent of the fish (EC50)

Safety Indices for Rainbow Trout and Channel Catfish at 12°C (54°F)

SpeciesExposure (min.)LC50 (mg/liter)EC50 (mg/liter)Index
Rainbow Trout1
         "
         "
Channel Catfish2
          "
          "		15
30
60
15
30
60
65
57
56
139
118
110		32
32
29
47
45
46		2.0
1.8
1.9
3.0
2.6
2.4

FROG TOXICITY STUDIES3 - Frogs were put into various concentrations of SYNCAINE for 30 minutes and then transferred to tap water in order to determine LC50. The LC50 was 6.2 percent SYNCAINE. Therefore, the anesthetic must be used in very high concentration before it is fatal to frogs.


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