FDA.reportPublic FDA data

NDC 61314-326-65 - ZARXIO

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
61314-326
Requested NDC
61314-326-65
Package NDCs from labels
61314-326-01, 61314-326-05, 61314-326-10, 61314-326-63, 61314-326-65, 61314-326-69
Manufacturer
Sandoz Inc.
Effective date
2025-08-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZARXIO - Sandoz Inc.Sandoz Inc.2025-08-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-326-01ZARXIO1 in 1 CARTONINJECTION, SOLUTION113
61314-326-01ZARXIO1 in 1 BLISTER PACKINJECTION, SOLUTION113
61314-326-05ZARXIO5 in 1 BLISTER PACKINJECTION, SOLUTION513
61314-326-05ZARXIO0.8 mL in 1 SYRINGEINJECTION, SOLUTION0.813
61314-326-10ZARXIO2 in 1 CARTONINJECTION, SOLUTION213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-326ZARXIO (FILGRASTIM-SNDZ) INJECTION, SOLUTION [SANDOZ INC.]12Current NDC, Legacy NDC, 5 package rows20241103_c0d1c22b-566b-4776-bdbf-00f96dad0cae.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-326-01ML - Milliliter61314-326d65370df-10ee-4ed3-9246-4d16941df2ed12018-06-11
61314-326-05ML - Milliliter61314-326f24c1802-285a-4de0-9b8a-c47aed2f27cb12018-09-05
61314-326-10ML - Milliliter61314-326a446ff1b-2dc6-4db0-87dc-d7615519777e12018-08-13

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 11 of 11 · 203 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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.