FDA.reportPublic FDA data

NYPOZI

Product NDC
72374-101
11-digit product format
723740101
Labeler code
72374
Product ID
72374-101_23d9f1d4-c25a-45fb-8095-986c659cb532
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
filgrastim-txid
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Tanvex BioPharma USA, Inc.
Application
BLA761126
Marketing category
BLA
Marketing start
2025-09-23
Substance
FILGRASTIM
Active strength
300 ug/300ug
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
NYPOZI
Brand name suffix
txid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FILGRASTIM300 ug/300ug

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
2700369Internal RxNorm lookup
2700376Internal RxNorm lookup
2700378Internal RxNorm lookup
2700379Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
89092bb8-6a20-e23e-e053-2a95a90aa750Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72374-101-01NYPOZItxid1 in 1 CARTONINJECTION15
72374-101-01NYPOZItxid300 ug in 1 SYRINGE, GLASSINJECTION3005
72374-101-10NYPOZItxid300 ug in 1 SYRINGE, GLASSINJECTION3005
72374-101-10NYPOZItxid10 in 1 CARTONINJECTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72374-101-01ML - Milliliter72374-10163be0e4a-379a-4838-88de-ad922f86f7f912024-12-10
72374-101-10ML - Milliliter72374-1016b11db65-2c66-4dad-9dc6-03950f91626d12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72374-101NYPOZI TXID (FILGRASTIM-TXID) INJECTION [TANVEX BIOPHARMA USA, INC.]4Current NDC, 4 package rows20241228_89092bb8-6a20-e23e-e053-2a95a90aa750.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NYPOZI txidFILGRASTIM-TXIDTanvex BioPharma USA, Inc.89092bb8-6a20-e23e-e053-2a95a90aa7502026-01-15Warnings, Adverse reactionsExact identifier
application number: BLA761126
ndc (product): 72374-101
NYPOZIFILGRASTIM-TXIDCipla USA Inc.575d164d-45fa-4e3e-81e4-2652d96673d12025-05-01Warnings, Adverse reactionsExact identifier
application number: BLA761126

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761126Nypozifilgrastim-txid351(k) BiosimilarRx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2700369filgrastim-txid 300 MCG in 0.5 ML Prefilled SyringePSN89092bb8-6a20-e23e-e053-2a95a90aa7505
2700378filgrastim-txid 480 MCG in 0.8 ML Prefilled SyringePSN89092bb8-6a20-e23e-e053-2a95a90aa7505
2700376NYPOZI 300 MCG in 0.5 ML Prefilled SyringePSN89092bb8-6a20-e23e-e053-2a95a90aa7505
2700379NYPOZI 480 MCG in 0.8 ML Prefilled SyringePSN89092bb8-6a20-e23e-e053-2a95a90aa7505
27003760.5 ML filgrastim-txid 0.6 MG/ML Prefilled Syringe [Nypozi]SBD89092bb8-6a20-e23e-e053-2a95a90aa7505
27003790.8 ML filgrastim-txid 0.6 MG/ML Prefilled Syringe [Nypozi]SBD89092bb8-6a20-e23e-e053-2a95a90aa7505
27003690.5 ML filgrastim-txid 0.6 MG/ML Prefilled SyringeSCD89092bb8-6a20-e23e-e053-2a95a90aa7505
27003780.8 ML filgrastim-txid 0.6 MG/ML Prefilled SyringeSCD89092bb8-6a20-e23e-e053-2a95a90aa7505
2700369filgrastim-txid 300 MCG per 0.5 ML Prefilled SyringeSY89092bb8-6a20-e23e-e053-2a95a90aa7505
2700378filgrastim-txid 480 MCG per 0.8 ML Prefilled SyringeSY89092bb8-6a20-e23e-e053-2a95a90aa7505
2700376Nypozi 0.6 MG/ML per 0.5 ML Prefilled SyringeSY89092bb8-6a20-e23e-e053-2a95a90aa7505
2700379Nypozi 0.6 MG/ML per 0.8 ML Prefilled SyringeSY89092bb8-6a20-e23e-e053-2a95a90aa7505
2700376Nypozi 300 MCG per 0.5 ML Prefilled SyringeSY89092bb8-6a20-e23e-e053-2a95a90aa7505
2700379Nypozi 480 MCG per 0.8 ML Prefilled SyringeSY89092bb8-6a20-e23e-e053-2a95a90aa7505

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72374-101-01723740101011 SYRINGE, GLASS in 1 CARTON (72374-101-01) / 300 ug in 1 SYRINGE, GLASS2025-09-23NoNoCurrent
72374-101-107237401011010 SYRINGE, GLASS in 1 CARTON (72374-101-10) / 300 ug in 1 SYRINGE, GLASS2025-09-23NoNoCurrent