FDA.reportPublic FDA data

NYPOZI

Product NDC
72374-102
11-digit product format
723740102
Labeler code
72374
Product ID
72374-102_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
480 ug/480ug
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
FILGRASTIM480 ug/480ug

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPVI5M0M1GW
Rxcui2700369, 2700376, 2700378, 2700379

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
72374-102-01NYPOZItxid480 ug in 1 SYRINGE, GLASSINJECTION4805
72374-102-01NYPOZItxid1 in 1 CARTONINJECTION15
72374-102-10NYPOZItxid480 ug in 1 SYRINGE, GLASSINJECTION4805
72374-102-10NYPOZItxid10 in 1 CARTONINJECTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72374-102-01ML - Milliliter72374-10223a7aa93-4e0b-41ab-ba92-b124b2366fee12024-12-10
72374-102-10ML - Milliliter72374-1026d3f6213-4029-4689-bee8-3eb4a9210dcc12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72374-102NYPOZI TXID (FILGRASTIM-TXID) INJECTION [TANVEX BIOPHARMA USA, INC.]4Current NDC, 4 package rows20241228_89092bb8-6a20-e23e-e053-2a95a90aa750.zip

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
72374-102-01723740102011 SYRINGE, GLASS in 1 CARTON (72374-102-01) / 480 ug in 1 SYRINGE, GLASS2025-09-23NoNoHistorical
72374-102-107237401021010 SYRINGE, GLASS in 1 CARTON (72374-102-10) / 480 ug in 1 SYRINGE, GLASS2025-09-23NoNoHistorical