FDA.reportPublic FDA data

NYPOZI

Product NDC
69097-430
11-digit product format
690970430
Labeler code
69097
Product ID
69097-430_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
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FILGRASTIM300 ug/300ug

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
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
69097-430-67NYPOZI300 ug in 1 SYRINGE, GLASSINJECTION3001
69097-430-67NYPOZI1 in 1 CARTONINJECTION11
69097-430-96NYPOZI300 ug in 1 SYRINGE, GLASSINJECTION3001
69097-430-96NYPOZI10 in 1 CARTONINJECTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-430-67ML - Milliliter69097-430f671a121-df3f-4149-a762-63367fc1f5d112026-03-17
69097-430-96ML - Milliliter69097-4300e07c018-abce-4025-bb57-c1525fdca03e12026-03-17

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
69097-430-67690970430671 SYRINGE, GLASS in 1 CARTON (69097-430-67) / 300 ug in 1 SYRINGE, GLASS2026-02-11NoNoCurrent
69097-430-966909704309610 SYRINGE, GLASS in 1 CARTON (69097-430-96) / 300 ug in 1 SYRINGE, GLASS2026-02-11NoNoCurrent