NDC 58198-5535 - Entyce

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 58198-5535
Package NDCs from labels: 58198-5535-1, 58198-5535-2, 58198-5535-3
Manufacturer: Elanco US Inc.
Effective date: 2025-11-19
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Entyce - Elanco US Inc.	Elanco US Inc.	2025-11-19	PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58198-5535-1	Entyce	10 mL in 1 BOTTLE, PLASTIC	SOLUTION	10	5
58198-5535-1	Entyce	1 in 1 CARTON	SOLUTION	1	5
58198-5535-2	Entyce	1 in 1 CARTON	SOLUTION	1	5
58198-5535-2	Entyce	15 mL in 1 BOTTLE, PLASTIC	SOLUTION	15	5
58198-5535-3	Entyce	1 in 1 CARTON	SOLUTION	1	5
58198-5535-3	Entyce	30 mL in 1 BOTTLE, PLASTIC	SOLUTION	30	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58198-5535	ENTYCE (CAPROMORELIN TARTRATE) SOLUTION [ELANCO US INC.]	4	6 package rows	20210811_0a403b74-72be-4f90-a069-d747caea1247.zip

Reported adverse events (FAERS/openFDA)#

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