FDA.reportPublic FDA data

ZIEXTENZO

Product NDC
61314-866
11-digit product format
613140866
Labeler code
61314
Product ID
61314-866_e37e846d-7231-4a75-a336-a9bc1dc5f61b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pegfilgrastim-bmez
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Sandoz Inc
Application
BLA761045
Marketing category
BLA
Marketing start
2019-11-04
Substance
PEGFILGRASTIM
Active strength
6 mg/.6mL
Pharmacologic classes
Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61314-86661314-866-01DDiscontinued by firm2026-08-17

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEGFILGRASTIM6 mg/.6mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3A58010674Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2260704Internal RxNorm lookup
2260709Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7dada041-6528-4acf-809c-62d271538c9aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7979a9c8-e75a-40a9-87cc-a5f08355aaefProduct name120230626
c3bb58c9-5c71-4b39-a70d-70acbffd3efeProduct name120230127
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
4217ae0d-ff4c-46f5-9e69-8cb4b72b3e37Product name120150402
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-08-03These highlights do not include all the information needed to use ZIEXTENZO safely and effectively. See full prescribing information for ZIEXTENZO. ZIEXTENZO ® (pegfilgrastim-bmez) injection, for subcutaneous use Initial U.S. Approval: 2019 ZIEXTENZO (pegfilgrastim-bmez) is biosimilar* to NEULASTA ® (pegfilgrastim).
2023-08-03These highlights do not include all the information needed to use ZIEXTENZO safely and effectively. See full prescribing information for ZIEXTENZO. ZIEXTENZO ® (pegfilgrastim-bmez) injection, for subcutaneous use Initial U.S. Approval: 2019 ZIEXTENZO (pegfilgrastim-bmez) is biosimilar* to NEULASTA ® (pegfilgrastim).
2023-08-03These highlights do not include all the information needed to use ZIEXTENZO safely and effectively. See full prescribing information for ZIEXTENZO. ZIEXTENZO ® (pegfilgrastim-bmez) injection, for subcutaneous use Initial U.S. Approval: 2019 ZIEXTENZO (pegfilgrastim-bmez) is biosimilar* to NEULASTA ® (pegfilgrastim).
2023-07-28These highlights do not include all the information needed to use ZIEXTENZO safely and effectively. See full prescribing information for ZIEXTENZO. ZIEXTENZO ® (pegfilgrastim-bmez) injection, for subcutaneous use Initial U.S. Approval: 2019 ZIEXTENZO (pegfilgrastim-bmez) is biosimilar* to NEULASTA ® (pegfilgrastim).
2023-07-28These highlights do not include all the information needed to use ZIEXTENZO safely and effectively. See full prescribing information for ZIEXTENZO. ZIEXTENZO ® (pegfilgrastim-bmez) injection, for subcutaneous use Initial U.S. Approval: 2019 ZIEXTENZO (pegfilgrastim-bmez) is biosimilar* to NEULASTA ® (pegfilgrastim).
2023-07-28These highlights do not include all the information needed to use ZIEXTENZO safely and effectively. See full prescribing information for ZIEXTENZO. ZIEXTENZO ® (pegfilgrastim-bmez) injection, for subcutaneous use Initial U.S. Approval: 2019 ZIEXTENZO (pegfilgrastim-bmez) is biosimilar* to NEULASTA ® (pegfilgrastim).

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-866-01ZIEXTENZO1 in 1 CARTONINJECTION122
61314-866-01ZIEXTENZO1 in 1 BLISTER PACKINJECTION122
61314-866-02ZIEXTENZO1 in 1 BLISTER PACKINJECTION122
61314-866-02ZIEXTENZO1 in 1 CARTONINJECTION122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-866-01ML - Milliliter61314-866513bf751-d559-47d1-9949-4ad72a450c2412019-12-10
61314-866-02ML - Milliliter61314-866768dc46e-ecdb-4764-a2dd-e730999f659a12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-866ZIEXTENZO (PEGFILGRASTIM-BMEZ) INJECTION [SANDOZ INC]19Current NDC, Legacy NDC, 4 package rows20250215_7dada041-6528-4acf-809c-62d271538c9a.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
ZIEXTENZOPEGFILGRASTIM-BMEZSandoz Inc7dada041-6528-4acf-809c-62d271538c9a2026-05-14Warnings, Adverse reactionsExact identifier
application number: BLA761045
ndc (product): 61314-866

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761045Ziextenzopegfilgrastim-bmez351(k) BiosimilarRx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2260704pegfilgrastim-bmez 6 MG in 0.6 ML Prefilled SyringePSN7dada041-6528-4acf-809c-62d271538c9a22
2260709Ziextenzo 6 MG in 0.6 ML Prefilled SyringePSN7dada041-6528-4acf-809c-62d271538c9a22
22607090.6 ML pegfilgrastim-bmez 10 MG/ML Prefilled Syringe [Ziextenzo]SBD7dada041-6528-4acf-809c-62d271538c9a22
22607040.6 ML pegfilgrastim-bmez 10 MG/ML Prefilled SyringeSCD7dada041-6528-4acf-809c-62d271538c9a22
22607090.6 ML Ziextenzo 10 MG/ML Prefilled SyringeSY7dada041-6528-4acf-809c-62d271538c9a22
2260704pegfilgrastim-bmez 10 MG/ML per 0.6 ML Prefilled SyringeSY7dada041-6528-4acf-809c-62d271538c9a22
2260704pegfilgrastim-bmez 6 MG per 0.6 ML Prefilled SyringeSY7dada041-6528-4acf-809c-62d271538c9a22
2260709Ziextenzo 6 MG per 0.6 ML Prefilled SyringeSY7dada041-6528-4acf-809c-62d271538c9a22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-866-01613140866011 BLISTER PACK in 1 CARTON (61314-866-01) > 1 SYRINGE in 1 BLISTER PACK > .6 mL in 1 SYRINGE1 blister pack2019-11-040000-00-00NoNoCurrent
61314-866-02613140866021 BLISTER PACK in 1 CARTON (61314-866-02) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE1 blister pack2025-03-03NoNoCurrent