54771-2671

Product NDC: 54771-2671
11-digit product format: 547712671
Labeler code: 54771
Product ID: 54771-2671_8ecbd590-40ae-4553-80d4-0e07bfb0afb2
Type: DRUG FOR FURTHER PROCESSING
Nonproprietary name: sarolaner, moxidectin, and pyrantel
Dosage form: TABLET, CHEWABLE
Marketing category: DRUG FOR FURTHER PROCESSING
Marketing start: 2020-02-19
Substance: SAROLANER; PYRANTEL PAMOATE; MOXIDECTIN
Active strength: 72 mg/1; 300 mg/1; 1.44 mg/1
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished product	product	54771-2671		UNFINISHED	Active or certified unfinished drug listing		2026-10-05
unfinished package	package	54771-2671	54771-2671-0	UNFINISHED	Active or certified unfinished drug listing		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	54771-2671-0	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	54771-2671-0	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	54771-2671-0	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	54771-2671-0	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	54771-2671-0	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	54771-2671-0	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	54771-2671-0	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	54771-2671-0	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	54771-2671-0	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	54771-2671-0	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	54771-2671-0	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	54771-2671-0	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	54771-2671-0	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	54771-2671-0	`50b4072663b7…`	`eae3003ed65e…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	54771-2671-0	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	54771-2671-0	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	54771-2671-0	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	54771-2671-0	`4bd3596a7b87…`	`5c64c6f6865f…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: No
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SAROLANER	72 mg/1
PYRANTEL PAMOATE	300 mg/1
MOXIDECTIN	1.44 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ece42924-1f10-42a5-af85-87a1c603c9c4	Product name	1	20180807

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54771-2671-1	Simparica TRIO	1 in 1 CARTON	TABLET, CHEWABLE	1	21
54771-2671-1	Simparica TRIO	1 in 1 BLISTER PACK	TABLET, CHEWABLE	1	21
54771-2671-2	Simparica TRIO	1 in 1 CARTON	TABLET, CHEWABLE	1	21
54771-2671-2	Simparica TRIO	3 in 1 BLISTER PACK	TABLET, CHEWABLE	3	21
54771-2671-3	Simparica TRIO	3 in 1 BLISTER PACK	TABLET, CHEWABLE	3	21
54771-2671-3	Simparica TRIO	2 in 1 CARTON	TABLET, CHEWABLE	2	21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54771-2671	SIMPARICA TRIO (SAROLANER, MOXIDECTIN, AND PYRANTEL) TABLET, CHEWABLE [ZOETIS INC.]	21	6 package rows	20250524_0f83bcf4-7e89-479f-a980-4cb40456ee78.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
DM113FTW7F	SAROLANER	1398609-39-6	SAROLANER
81BK194Z5M	PYRANTEL PAMOATE	22204-24-6	PYRANTEL PAMOATE
NGU5H31YO9	MOXIDECTIN	113507-06-5	MOXIDECTIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2281753	moxidectin 0.06 MG / pyrantel pamoate 12.5 MG / sarolaner 3 MG Chewable Tablet	PSN	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281765	moxidectin 0.12 MG / pyrantel pamoate 25 MG / sarolaner 6 MG Chewable Tablet	PSN	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281736	moxidectin 0.24 MG / pyrantel pamoate 50 MG / sarolaner 12 MG Chewable Tablet	PSN	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281747	moxidectin 0.48 MG / pyrantel pamoate 100 MG / sarolaner 24 MG Chewable Tablet	PSN	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281759	moxidectin 0.96 MG / pyrantel pamoate 200 MG / sarolaner 48 MG Chewable Tablet	PSN	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281771	moxidectin 1.44 MG / pyrantel pamoate 300 MG / sarolaner 72 MG Chewable Tablet	PSN	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281755	Simparica TRIO 0.06 MG / 12.5 MG / 3 MG Chewable Tablet	PSN	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281767	Simparica TRIO 0.12 MG / 25 MG / 6 MG Chewable Tablet	PSN	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281743	Simparica TRIO 0.24 MG / 50 MG / 12 MG Chewable Tablet	PSN	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281749	Simparica TRIO 0.48 MG / 100 MG / 24 MG Chewable Tablet	PSN	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281761	Simparica TRIO 0.96 MG / 200 MG / 48 MG Chewable Tablet	PSN	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281773	Simparica TRIO 1.44 MG / 300 MG / 72 MG Chewable Tablet	PSN	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281755	moxidectin 0.06 MG / pyrantel pamoate 12.5 MG / sarolaner 3 MG Chewable Tablet [Simparica TRIO]	SBD	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281767	moxidectin 0.12 MG / pyrantel pamoate 25 MG / sarolaner 6 MG Chewable Tablet [Simparica TRIO]	SBD	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281743	moxidectin 0.24 MG / pyrantel pamoate 50 MG / sarolaner 12 MG Chewable Tablet [Simparica TRIO]	SBD	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281749	moxidectin 0.48 MG / pyrantel pamoate 100 MG / sarolaner 24 MG Chewable Tablet [Simparica TRIO]	SBD	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281761	moxidectin 0.96 MG / pyrantel pamoate 200 MG / sarolaner 48 MG Chewable Tablet [Simparica TRIO]	SBD	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281773	moxidectin 1.44 MG / pyrantel pamoate 300 MG / sarolaner 72 MG Chewable Tablet [Simparica TRIO]	SBD	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281753	moxidectin 0.06 MG / pyrantel pamoate 12.5 MG / sarolaner 3 MG Chewable Tablet	SCD	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281765	moxidectin 0.12 MG / pyrantel pamoate 25 MG / sarolaner 6 MG Chewable Tablet	SCD	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281736	moxidectin 0.24 MG / pyrantel pamoate 50 MG / sarolaner 12 MG Chewable Tablet	SCD	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281747	moxidectin 0.48 MG / pyrantel pamoate 100 MG / sarolaner 24 MG Chewable Tablet	SCD	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281759	moxidectin 0.96 MG / pyrantel pamoate 200 MG / sarolaner 48 MG Chewable Tablet	SCD	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281771	moxidectin 1.44 MG / pyrantel pamoate 300 MG / sarolaner 72 MG Chewable Tablet	SCD	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281755	Simparica TRIO (moxidectin 0.06 MG / pyrantel pamoate 12.5 MG / sarolaner 3 MG) Chewable Tablet	SY	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281767	Simparica TRIO (moxidectin 0.12 MG / pyrantel pamoate 25 MG / sarolaner 6 MG) Chewable Tablet	SY	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281743	Simparica TRIO (moxidectin 0.24 MG / pyrantel pamoate 50 MG / sarolaner 12 MG) Chewable Tablet	SY	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281749	Simparica TRIO (moxidectin 0.48 MG / pyrantel pamoate 100 MG / sarolaner 24 MG) Chewable Tablet	SY	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281761	Simparica TRIO (moxidectin 0.96 MG / pyrantel pamoate 200 MG / sarolaner 48 MG) Chewable Tablet	SY	0f83bcf4-7e89-479f-a980-4cb40456ee78	21
2281773	Simparica TRIO (moxidectin 1.44 MG / pyrantel pamoate 300 MG / sarolaner 72 MG) Chewable Tablet	SY	0f83bcf4-7e89-479f-a980-4cb40456ee78	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
54771-2671-0	54771267100	30 TABLET, CHEWABLE in 1 DRUM (54771-2671-0)	19-FEB-20	Current
54771-2671-1	54771267101	1 in 1 CARTON		Historical
54771-2671-2	54771267102	1 in 1 CARTON		Historical
54771-2671-3	54771267103	3 in 1 BLISTER PACK		Historical