NDC 58198-9019-4 - Increxxa

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: 58198-9019
Requested NDC: 58198-9019-4
Package NDCs from labels: 58198-9019-4, 58198-9019-1, 58198-9019-5, 58198-9019-2, 58198-9019-6, 58198-9019-3
Manufacturer: Elanco US Inc.
Effective date: 2025-11-07
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Increxxa - Elanco US Inc.	Elanco US Inc.	2025-11-07	PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58198-9019-1	Increxxa	12 in 1 CASE	INJECTION	12	5
58198-9019-2	Increxxa	12 in 1 CASE	INJECTION	12	5
58198-9019-3	Increxxa	6 in 1 CASE	INJECTION	6	5
58198-9019-4	Increxxa	100 mL in 1 BOTTLE, GLASS	INJECTION	100	5
58198-9019-4	Increxxa	1 in 1 CARTON	INJECTION	1	5
58198-9019-5	Increxxa	1 in 1 CARTON	INJECTION	1	5
58198-9019-5	Increxxa	250 mL in 1 BOTTLE, GLASS	INJECTION	250	5
58198-9019-6	Increxxa	1 in 1 CARTON	INJECTION	1	5
58198-9019-6	Increxxa	500 mL in 1 BOTTLE, GLASS	INJECTION	500	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58198-9019	INCREXXA (TULATHROMYCIN) INJECTION [ELANCO US INC.]	4	9 package rows	20250206_4c9dca16-c5b9-4f43-8b05-30bc63cb140a.zip

Reported adverse events (FAERS/openFDA)#

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