FDA.reportPublic FDA data

NDC 0641-6147-01 - 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
0641-6147
Requested NDC
0641-6147-01
Package NDCs from labels
0641-6147-01, 0641-6147-10, 0641-6147-25
Manufacturer
Henry Schein, Inc.
Effective date
2025-08-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sterile Water for Injection USPHenry Schein, Inc.2025-08-28HUMAN PRESCRIPTION DRUG LABEL
Sterile Water for Injection, USPHikma Pharmaceuticals USA Inc.2024-04-10HUMAN PRESCRIPTION DRUG LABEL
Sterile WaterGeneral Injectables and Vaccines, Inc.2019-06-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6147-01Sterile Water10 mL in 1 VIALINJECTION, SOLUTION1012
0641-6147-10Sterile Water10 in 1 CARTONINJECTION, SOLUTION1012
0641-6147-25Sterile Water25 in 1 CARTONINJECTION, SOLUTION2512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6147STERILE WATER (WATER) INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]12Current NDC, Legacy NDC, 3 package rows20240412_78ef7ad3-451d-43d0-a9b6-5cf0aadca003.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6147-01ML - Milliliter0641-614764ef0224-9469-4b15-98fa-4ae09f98ac0e12018-08-13
0641-6147-10ML - Milliliter0641-61470495bb78-5321-4be7-b963-f68ffc4bb2b412019-11-12
0641-6147-25ML - Milliliter0641-61473a15b7df-eeee-445c-b2c2-bf211870cd7912018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WATERACTIVE INGREDIENT059QF0KO0RSTERILE WATER (WATER) INJECTION, SOLUTION [WEST-WARD PHARMACEUTICALS CORP.]6
WATERACTIVE MOIETY059QF0KO0RSTERILE WATER (WATER) INJECTION, SOLUTION [WEST-WARD PHARMACEUTICALS CORP.]6

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 · 162 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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