Simparica TRIO: Product Information (Page 3 of 3)

STORAGE CONDITIONS

Store at or below 30°C (86°F).

HOW SUPPLIED

SIMPARICA TRIO is available in six flavored tablet sizes (see DOSAGE AND ADMINISTRATION). Each tablet size is available in packages of one, three, or six tablets.

Approved by FDA under NADA # 141‑521
zoetis
Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007
Revised: August 202051000402

PRINCIPAL DISPLAY PANEL — 3mg x 1 Carton

3mg x 1 Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 6mg x 1 Carton

6mg x 1 Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 12mg x 1 Carton

12mg x 1 Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 24mg x 1 Carton

24mg x 1 Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 48mg x 1 Carton

48mg x 1 Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 72mg x 1 Carton

72mg x 1 Carton
(click image for full-size original)

SIMPARICA TRIO sarolaner, moxidectin, and pyrantel tablet, chewable
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-2667
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAROLANER (SAROLANER) SAROLANER 3 mg
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN .06 mg
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL 12.5 mg
Product Characteristics
Color brown (reddish brown) Score no score
Shape PENTAGON (5 sided) (rounded edges) Size 9mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-2667-1 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (54771-2667-1)
2 NDC:54771-2667-2 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 3 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (54771-2667-2)
3 NDC:54771-2667-3 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 6 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (54771-2667-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141521 03/02/2020
SIMPARICA TRIO sarolaner, moxidectin, and pyrantel tablet, chewable
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-2684
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAROLANER (SAROLANER) SAROLANER 6 mg
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN .12 mg
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL 25 mg
Product Characteristics
Color brown (reddish brown) Score no score
Shape PENTAGON (5 sided) (rounded edges) Size 11mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-2684-1 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (54771-2684-1)
2 NDC:54771-2684-2 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 3 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (54771-2684-2)
3 NDC:54771-2684-3 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 6 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (54771-2684-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141521 03/02/2020
SIMPARICA TRIO sarolaner, moxidectin, and pyrantel tablet, chewable
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-2668
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAROLANER (SAROLANER) SAROLANER 12 mg
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN .24 mg
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL 50 mg
Product Characteristics
Color brown (reddish brown) Score no score
Shape PENTAGON (5 sided) (rounded edges) Size 14mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-2668-1 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (54771-2668-1)
2 NDC:54771-2668-2 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 3 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (54771-2668-2)
3 NDC:54771-2668-3 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 6 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (54771-2668-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141521 03/02/2020
SIMPARICA TRIO sarolaner, moxidectin, and pyrantel tablet, chewable
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-2669
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAROLANER (SAROLANER) SAROLANER 24 mg
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN .48 mg
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL 100 mg
Product Characteristics
Color brown (reddish brown) Score no score
Shape PENTAGON (5 sided) (rounded edges) Size 17mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-2669-1 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (54771-2669-1)
2 NDC:54771-2669-2 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 3 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (54771-2669-2)
3 NDC:54771-2669-3 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 3 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (54771-2669-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141521 03/02/2020
SIMPARICA TRIO sarolaner, moxidectin, and pyrantel tablet, chewable
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-2670
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAROLANER (SAROLANER) SAROLANER 48 mg
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN .96 mg
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL 200 mg
Product Characteristics
Color brown (reddish brown) Score no score
Shape PENTAGON (5 sided) (rounded edges) Size 20mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-2670-1 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (54771-2670-1)
2 NDC:54771-2670-2 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 3 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (54771-2670-2)
3 NDC:54771-2670-3 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 3 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (54771-2670-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141521 03/02/2020
SIMPARICA TRIO sarolaner, moxidectin, and pyrantel tablet, chewable
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-2671
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAROLANER (SAROLANER) SAROLANER 72 mg
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN 1.44 mg
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL 300 mg
Product Characteristics
Color brown (reddish brown) Score no score
Shape PENTAGON (5 sided) (rounded edges) Size 24mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-2671-1 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (54771-2671-1)
2 NDC:54771-2671-2 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 3 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (54771-2671-2)
3 NDC:54771-2671-3 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 3 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (54771-2671-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141521 03/02/2020
Labeler — Zoetis Inc. (828851555)

Revised: 10/2021 Zoetis Inc.

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