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

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 Identifiers#

Field, Values table
FieldValues
Unii3A58010674
Rxcui2260704, 2260709

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61314-866-012023-08-03C16284748780-10191ceaa-6d35-198a-e063-dbdaa90aec3eThese 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).
61314-866-012023-08-03C16284748780-10191ceaa-6d35-198a-e063-dbdaa90aec3eThese 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).
61314-866-012023-08-03C16284748780-10191ceaa-6d35-198a-e063-dbdaa90aec3eThese 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).
61314-866-012023-07-28C16284748780-10191ceaa-6d35-198a-e063-dbdaa90aec3eThese 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).
61314-866-012023-07-28C16284748780-10191ceaa-6d35-198a-e063-dbdaa90aec3eThese 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).
61314-866-012023-07-28C16284748780-10191ceaa-6d35-198a-e063-dbdaa90aec3eThese 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

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 pack2025-03-03NoNoHistorical