FDA.reportPublic FDA data

ZARXIO

Product NDC
61314-318
11-digit product format
613140318
Labeler code
61314
Product ID
61314-318_5047f866-a689-466d-9808-52138bd638c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
filgrastim-sndz
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Sandoz Inc.
Application
BLA125553
Marketing category
BLA
Marketing start
2015-03-06
Substance
FILGRASTIM
Active strength
300 ug/.5mL
Pharmacologic classes
Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZARXIO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FILGRASTIM300 ug/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PVI5M0M1GWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1605066Internal RxNorm lookup
1605071Internal RxNorm lookup
1605074Internal RxNorm lookup
1605075Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c0d1c22b-566b-4776-bdbf-00f96dad0caeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f366651-2cb6-4932-a760-2ae84fd8fbffProduct name120230703
3b1c6100-f679-4300-94a6-3b3fc05b0c44Product name120230110
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-318-01ZARXIO1 in 1 BLISTER PACKINJECTION, SOLUTION113
61314-318-01ZARXIO1 in 1 CARTONINJECTION, SOLUTION113
61314-318-05ZARXIO5 in 1 BLISTER PACKINJECTION, SOLUTION513
61314-318-05ZARXIO0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.513
61314-318-10ZARXIO2 in 1 CARTONINJECTION, SOLUTION213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-318-01ML - Milliliter61314-3181d9e54d8-23fa-4729-936f-b0314d455cbf12018-06-11
61314-318-05ML - Milliliter61314-318ac757403-b3bb-4a50-8152-023a6e1c41d112018-09-05
61314-318-10ML - Milliliter61314-318753ae9f2-eae2-45a0-8f32-0954088e28ff12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-318ZARXIO (FILGRASTIM-SNDZ) INJECTION, SOLUTION [SANDOZ INC.]12Current NDC, Legacy NDC, 5 package rows20241103_c0d1c22b-566b-4776-bdbf-00f96dad0cae.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZARXIOFILGRASTIM-SNDZSandoz Inc.c0d1c22b-566b-4776-bdbf-00f96dad0cae2025-08-29Warnings, Adverse reactionsExact identifier
application number: BLA125553
ndc (product): 61314-318

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125553Zarxiofilgrastim-sndz351(k) BiosimilarRx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1605066filgrastim-sndz 300 MCG in 0.5 ML Prefilled SyringePSNc0d1c22b-566b-4776-bdbf-00f96dad0cae13
1605074filgrastim-sndz 480 MCG in 0.8 ML Prefilled SyringePSNc0d1c22b-566b-4776-bdbf-00f96dad0cae13
1605071Zarxio 300 MCG in 0.5 ML Prefilled SyringePSNc0d1c22b-566b-4776-bdbf-00f96dad0cae13
1605075Zarxio 480 MCG in 0.8 ML Prefilled SyringePSNc0d1c22b-566b-4776-bdbf-00f96dad0cae13
16050710.5 ML filgrastim-sndz 0.6 MG/ML Prefilled Syringe [Zarxio]SBDc0d1c22b-566b-4776-bdbf-00f96dad0cae13
16050750.8 ML filgrastim-sndz 0.6 MG/ML Prefilled Syringe [Zarxio]SBDc0d1c22b-566b-4776-bdbf-00f96dad0cae13
16050660.5 ML filgrastim-sndz 0.6 MG/ML Prefilled SyringeSCDc0d1c22b-566b-4776-bdbf-00f96dad0cae13
16050740.8 ML filgrastim-sndz 0.6 MG/ML Prefilled SyringeSCDc0d1c22b-566b-4776-bdbf-00f96dad0cae13
16050710.5 ML Zarxio 0.6 MG/ML Prefilled SyringeSYc0d1c22b-566b-4776-bdbf-00f96dad0cae13
16050750.8 ML Zarxio 0.6 MG/ML Prefilled SyringeSYc0d1c22b-566b-4776-bdbf-00f96dad0cae13
1605066filgrastim-sndz 300 MCG per 0.5 ML Prefilled SyringeSYc0d1c22b-566b-4776-bdbf-00f96dad0cae13
1605074filgrastim-sndz 480 MCG per 0.8 ML Prefilled SyringeSYc0d1c22b-566b-4776-bdbf-00f96dad0cae13
1605071Zarxio 300 MCG per 0.5 ML Prefilled SyringeSYc0d1c22b-566b-4776-bdbf-00f96dad0cae13
1605075Zarxio 480 MCG per 0.8 ML Prefilled SyringeSYc0d1c22b-566b-4776-bdbf-00f96dad0cae13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-318-01613140318011 BLISTER PACK in 1 CARTON (61314-318-01) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE1 blister pack2018-02-220000-00-00NoNoCurrent
61314-318-05613140318055 in 1 BLISTER PACKHistorical
61314-318-10613140318102 BLISTER PACK in 1 CARTON (61314-318-10) / 5 SYRINGE in 1 BLISTER PACK (61314-318-05) / .5 mL in 1 SYRINGE2 blister pack2018-02-220000-00-00NoNoCurrent
61314-318-63613140318631 BLISTER PACK in 1 CARTON (61314-318-63) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE1 blister pack2026-06-120Current
61314-318-69613140318692 BLISTER PACK in 1 CARTON (61314-318-69) / 5 SYRINGE in 1 BLISTER PACK (61314-318-65) / .5 mL in 1 SYRINGE2 blister pack2026-06-120Current