NDC 0409-4596-01 - Precedex

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: 0409-4596
Requested NDC: 0409-4596-01
Package NDCs from labels: 0409-4596-01, 0409-4596-20
Manufacturer: Hospira, Inc. | Terumo BCT Ltd
Effective date: 2026-06-17
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Precedex - Hospira, Inc. \| Terumo BCT Ltd	Hospira, Inc. \| Terumo BCT Ltd	2026-06-17	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0409-4596-01	Precedex	50 mL in 1 BOTTLE	INJECTION, SOLUTION	50		5
0409-4596-20	Precedex	20 in 1 TRAY	INJECTION, SOLUTION	20		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-4596	PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20250316_92b7ddaa-e45a-4b64-a802-bb5df8771dd6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-4596-01	ML - Milliliter	0409-4596	c2d3fdc9-ebc3-4c43-a42c-ee59edbcbeb6	1	2023-02-06
0409-4596-20	ML - Milliliter	0409-4596	a9123f55-0132-494f-bbcc-c48e590681d2	1	2023-02-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 51 of 51 · 1,001 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12		Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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