Label: THYROCRYN- levoxine powder

  • NDC Code(s): 46066-174-20, 46066-174-22
  • Packager: Aspen Veterinary Resources
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 27, 2024

If you are a consumer or patient please visit this version.

  • INFORMATION FOR OWNERS/CAREGIVERS

    A palatable supplement for the correction of conditions associated with hypothyroidism in horses and ponies

    WARNING: Federal law restricts this drug to use by or on the order of a licensed veterinarian

    Not for Use in Humans • Keep Out of Reach of Children

  • INDICATIONS:

    For use in horses and ponies for correction of conditions associated with low circulating thyroid hormone (hypothyrodism).

  • DOSAGE:

    Doses should be individualized and animals should be monitored daily for clinical signs of hyperthyroidism or hypersensitivity. Suggested initial doses are 1-10 mg levothyroxine sodium (T4)/100 lb body weight (2-20 mg/100 kg) once per day or in divided doses. Response to the administration of Thyrocryn™ Powder should be evaluated clinically every week until an adequate maintenance dose is established. In most horses, this is usually in the range of 35 to 100 mg total daily dose of T4 (1-3 level tablespoonfuls Thyrocryn™ Powder ).

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  • INGREDIENTS:

    Each pound (453.6 g) contains:

    Levothyroxine Sodium USP  ........................................  0.22% (1.0 g)

    One level teaspoonful contains 12 mg of T4: one level tablespoonful contains 36 mg of T4.

  • WARNING:

    Administer with caution to animals with clincially significant heart disease, hypertension or other complications for which a sharply increased metabolic rate might prove hazardous.  Use in pregnant mares has not been evaluated.

  • STORAGE AND HANDLING

    STORAGE: Store at controlled room temperature between 15° - 30°C (59° - 86°F).  Keep container tightly closed when not in use.

    USE ONLY AS DIRECTED

  • HOW SUPPLIED

    Net Contents:

    1 lb (453.6 grams), P0172.FP

    10 lb (4.5 kg), P0173.FP

  • 1 lb (453.6 g)

    image of container label 1 lb

    image of container case label 1 lb

  • 10 lb (4.5 kg)

    image of container label 10 lb

  • INGREDIENTS AND APPEARANCE
    THYROCRYN 
    levoxine powder
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:46066-174
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS1000 mg  in 453.6 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46066-174-2012 in 1 CASE
    1453.6 g in 1 JAR
    2NDC:46066-174-224500 g in 1 PAIL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/27/2024
    Labeler - Aspen Veterinary Resources (627265361)
    Registrant - Firs t Priority Incorporated (179925722)
    Establishment
    NameAddressID/FEIBusiness Operations
    First Priority Incorporated179925722manufacture