MedPath

Panacur

panacur (fenbendazole)

Approved
Approval ID

f050ba40-bb95-423c-a02b-b0f0c9a46830

Product Type

OTC ANIMAL DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

Merck Sharp & Dohme Corp.

DUNS: 001317601

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Fenbendazole

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57926-081
Application NumberNADA120648
Product Classification
M
Marketing Category
C73593
G
Generic Name
Fenbendazole
Product Specifications
Route of AdministrationORAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (1)

FENBENDAZOLEActive
Quantity: 100 mg in 1 g
Code: 621BVT9M36
Classification: ACTIB

Fenbendazole

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57926-082
Application NumberNADA120648
Product Classification
M
Marketing Category
C73593
G
Generic Name
Fenbendazole
Product Specifications
Route of AdministrationORAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (1)

FENBENDAZOLEActive
Quantity: 100 mg in 1 g
Code: 621BVT9M36
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/7/2024

PRINCIPAL DISPLAY PANEL - 57 gram Syringe Carton

panacur®
(fenbendazole)

POWERPAC

Equine Dewormer

Controls Encysted EL3 Small Strongyle Larvae

Controls both larval & adult parasites

MERCK
Animal Health

Principal Display Panel - 57 gram Syringe Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/7/2024

INDICATIONS:

Panacur® Paste 10% is indicated for the treatment and control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), encysted early 3rd stage (hypobiotic), late 3rd stage and 4th stage cyathostome larvae, small strongyles, pinworms (Oxyuris equi), ascarids (Parascaris equorum), and for the control of arteritis caused by 4th stage larvae of Strongylus vulgaris in horses.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 11/7/2024

Fenbendazole (active ingred.) made in: see imprint. Formulated in France.

Distributed by:
Intervet Inc. (d/b/a Merck Animal Health)
Rahway, NJ 07065

Approved by FDA under NADA #120-648

©2023 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.

Rev. 7/23

MERCK
Animal Health

DESCRIPTION SECTION

LOINC: 34089-3Updated: 11/7/2024

DESCRIPTION:

Panacur® (fenbendazole) Paste 10% contains the active anthelmintic, fenbendazole. The chemical name of fenbendazole is methyl 5-(phenylthio)-2-benzimidazole carbamate.

The chemical structure is:

Chemical Structure

Each gram of Panacur® Paste 10% contains 100 mg of fenbendazole and is flavored with artificial apple-cinnamon liquid.

MECHANISM OF ACTION SECTION

LOINC: 43679-0Updated: 11/7/2024

ACTIONS:

The antiparasitic action of Panacur® Paste 10% is believed to be due to the inhibition of energy metabolism in the parasite.

PRECAUTIONS SECTION

LOINC: 42232-9Updated: 11/7/2024

PRECAUTIONS:

Side effects associated with Panacur® Paste 10% could not be established in well-controlled safety studies in horses with single doses as high as 454 mg/lb (1,000 mg/kg) and 15 consecutive daily doses of 22.7 mg/lb (50 mg/kg). Particularly with higher doses, the lethal action of fenbendazole may cause the release of antigens by the dying parasites. This phenomenon may result in either a local or systemic hypersensitivity reaction. As with any drug, these reactions should be treated symptomatically. Panacur® Paste 10% has been evaluated for safety in pregnant mares during all stages of gestation with doses as high as 11.4 mg/lb (25 mg/kg) and in stallions with doses as high as 11.4 mg/lb (25 mg/kg). No adverse effects on reproduction were detected. The recommended dose for control of 4th stage Strongylus vulgaris larvae, 4.6 mg/lb (10 mg/kg) daily for 5 consecutive days, has not been evaluated for safety in stallions or pregnant mares.

WARNINGS SECTION

LOINC: 34071-1Updated: 11/7/2024

WARNINGS:

NOT FOR USE IN HUMANS. KEEP OUT OF REACH OF CHILDREN. The Safety Data Sheet (SDS) contains more detailed occupational safety information. For customer service, adverse effects reporting, and/or a copy of the SDS, call 1-800-211-3573. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS, or http://www.fda.gov/reportanimalae.

FOOD SAFETY WARNING SECTION

LOINC: 50743-4Updated: 11/7/2024

OTHER WARNINGS: Do not use in horses intended for human consumption.

Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance. Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/7/2024

DOSAGE: Panacur® Paste 10% is administered orally at a rate of 2.3 mg/lb (5 mg/ kg) for the control of large strongyles, small strongyles, and pinworms. One syringe will deworm two 1,250 lb (568 kg) horses at a dose of 5 mg/kg. For foals and weanlings (less than 18 months of age) where ascarids are a common problem, the recommended dose is 4.6 mg/lb (10 mg/kg); one syringe will deworm a 1,250 lb horse.

For control of hypobiotic (encysted early 3rd stage), late 3rd stage, and 4th stage cyathostome larvae, as well as 4th stage Strongylus vulgaris larvae, the recommended dose is 4.6 mg/lb (10 mg/kg) daily for 5 consecutive days; administer one syringe for each 1,250 Ib body weight per day.

Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 11/7/2024

HOW SUPPLIED: Panacur® Paste 10% Equine Dewormer is supplied in 57 gram syringes, 5 per carton.

Store at or below 25°C (77°F).

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Panacur - FDA Drug Approval Details