NDC 65219-495-01 - Sterile Water

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: 65219-495
Requested NDC: 65219-495-01
Package NDCs from labels: 65219-495-01, 65219-495-10
Manufacturer: Fresenius Kabi USA, LLC | Fresenius Kabi Deutschland GmbH
Effective date: 2025-11-18
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Sterile Water - Fresenius Kabi USA, LLC \| Fresenius Kabi Deutschland GmbH	Fresenius Kabi USA, LLC \| Fresenius Kabi Deutschland GmbH	2025-11-18	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65219-495-01	Sterile Water	1000 mL in 1 BAG	INJECTION	1000		4
65219-495-10	Sterile Water	6 in 1 CASE	INJECTION	6		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65219-495	STERILE WATER (WATER) INJECTION [FRESENIUS KABI USA, LLC]	2	Current NDC, 2 package rows	20250402_fd823bef-c14c-4708-a18a-8aaa8470412f.zip

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 9 of 9 · 161 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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