FDA.reportPublic FDA data

NYPOZI

Product NDC
69097-429
11-digit product format
690970429
Labeler code
69097
Product ID
69097-429_6951a2d4-8d07-4197-a02c-2e5aed420f33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
filgrastim-txid
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Cipla USA Inc.
Application
BLA761126
Marketing category
BLA
Marketing start
2026-02-11
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FILGRASTIM480 ug/480ug

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
575d164d-45fa-4e3e-81e4-2652d96673d1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f366651-2cb6-4932-a760-2ae84fd8fbffProduct name120230703
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
3b1c6100-f679-4300-94a6-3b3fc05b0c44Product name120230110
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-429-67NYPOZI480 ug in 1 SYRINGE, GLASSINJECTION4801
69097-429-67NYPOZI1 in 1 CARTONINJECTION11
69097-429-96NYPOZI480 ug in 1 SYRINGE, GLASSINJECTION4801
69097-429-96NYPOZI10 in 1 CARTONINJECTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-429-67ML - Milliliter69097-42941911d9f-5b5e-4d1c-9178-81318a0fd34012026-03-17
69097-429-96ML - Milliliter69097-4292dc622cf-3d3f-4951-a4cd-c6358489fd3412026-03-17

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
NYPOZIFILGRASTIM-TXIDCipla USA Inc.575d164d-45fa-4e3e-81e4-2652d96673d12025-05-01Warnings, Adverse reactionsExact identifier
application number: BLA761126
ndc (product): 69097-429

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 SyringePSN575d164d-45fa-4e3e-81e4-2652d96673d11
2700378filgrastim-txid 480 MCG in 0.8 ML Prefilled SyringePSN575d164d-45fa-4e3e-81e4-2652d96673d11
2700376NYPOZI 300 MCG in 0.5 ML Prefilled SyringePSN575d164d-45fa-4e3e-81e4-2652d96673d11
2700379NYPOZI 480 MCG in 0.8 ML Prefilled SyringePSN575d164d-45fa-4e3e-81e4-2652d96673d11
27003760.5 ML filgrastim-txid 0.6 MG/ML Prefilled Syringe [Nypozi]SBD575d164d-45fa-4e3e-81e4-2652d96673d11
27003790.8 ML filgrastim-txid 0.6 MG/ML Prefilled Syringe [Nypozi]SBD575d164d-45fa-4e3e-81e4-2652d96673d11
27003690.5 ML filgrastim-txid 0.6 MG/ML Prefilled SyringeSCD575d164d-45fa-4e3e-81e4-2652d96673d11
27003780.8 ML filgrastim-txid 0.6 MG/ML Prefilled SyringeSCD575d164d-45fa-4e3e-81e4-2652d96673d11
2700369filgrastim-txid 300 MCG per 0.5 ML Prefilled SyringeSY575d164d-45fa-4e3e-81e4-2652d96673d11
2700378filgrastim-txid 480 MCG per 0.8 ML Prefilled SyringeSY575d164d-45fa-4e3e-81e4-2652d96673d11
2700376Nypozi 0.6 MG/ML per 0.5 ML Prefilled SyringeSY575d164d-45fa-4e3e-81e4-2652d96673d11
2700379Nypozi 0.6 MG/ML per 0.8 ML Prefilled SyringeSY575d164d-45fa-4e3e-81e4-2652d96673d11
2700376Nypozi 300 MCG per 0.5 ML Prefilled SyringeSY575d164d-45fa-4e3e-81e4-2652d96673d11
2700379Nypozi 480 MCG per 0.8 ML Prefilled SyringeSY575d164d-45fa-4e3e-81e4-2652d96673d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69097-429-67690970429671 SYRINGE, GLASS in 1 CARTON (69097-429-67) / 480 ug in 1 SYRINGE, GLASS2026-02-11NoNoCurrent
69097-429-966909704299610 SYRINGE, GLASS in 1 CARTON (69097-429-96) / 480 ug in 1 SYRINGE, GLASS2026-02-11NoNoCurrent