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 5 of 11 · 203 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aminosyn-PFISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINEICU Medical Inc.46e74ce4-cd7e-437f-bf54-ca9b98eb26632025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3KX376GY7L
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PerikabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCc2eb5522-8572-45f4-869d-42f9fd251bb62025-09-15Warnings, Adverse reactionsExact identifier
unii: 3KX376GY7L
KabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCafeb4837-a759-4484-a76e-e04611c459e72025-09-11Warnings, Adverse reactionsExact identifier
unii: 3KX376GY7L
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
ZARXIOFILGRASTIM-SNDZSandoz Inc.c0d1c22b-566b-4776-bdbf-00f96dad0cae2025-08-29Warnings, Adverse reactionsExact identifier
application number: BLA125553
ndc (package): 61314-326-65
ndc (package): 61314-318-10
ndc (package): 61314-326-10
ndc (package): 61314-318-01
ndc (package): 61314-326-63
ndc (package): 61314-318-05
ndc (package): 61314-318-69
ndc (package): 61314-326-69
ndc (package): 61314-318-65
ndc (package): 61314-326-05
ndc (package): 61314-318-63
ndc (package): 61314-326-01
ndc (product): 61314-318
ndc (product): 61314-326
ndc11 (package): 61314032665
rxcui: 1605075
rxcui: 1605071
rxcui: 1605066
rxcui: 1605074
spl id: f213544a-940c-4fd3-b769-d227ff6b76d0
spl set id: c0d1c22b-566b-4776-bdbf-00f96dad0cae
unii: PVI5M0M1GW
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NivestymFILGRASTIM-AAFIPfizer Laboratories Div Pfizer Incd23ab39c-b6ec-41cf-a529-9dd2852c9d9a2025-08-12Warnings, Adverse reactionsExact identifier
unii: PVI5M0M1GW
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
unii: 506T60A25R
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
NYPOZIFILGRASTIM-TXIDCipla USA Inc.575d164d-45fa-4e3e-81e4-2652d96673d12025-05-01Warnings, Adverse reactionsExact identifier
unii: PVI5M0M1GW
RELEUKOFILGRASTIMAmneal Pharmaceuticals LLC74e1ec6e-1630-4654-895c-2bd355f939e72025-04-24Warnings, Adverse reactionsExact identifier
unii: PVI5M0M1GW

Reported adverse events (FAERS/openFDA)#

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