FDA.reportPublic FDA data

FYLNETRA

Product NDC
70121-1627
11-digit product format
701211627
Labeler code
70121
Product ID
70121-1627_8cb6cfed-487e-4351-8f48-0be3cc5c2d6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pegfilgrastim
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Amneal Pharmaceuticals LLC
Application
BLA761084
Marketing category
BLA
Marketing start
2022-05-31
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FYLNETRA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEGFILGRASTIM6 mg/.6mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3A58010674
Rxcui2602781, 2602787

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-1627-1FYLNETRA0.6 mL in 1 SYRINGEINJECTION0.68
70121-1627-1FYLNETRA1 in 1 CARTONINJECTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1627-1ML - Milliliter70121-16275f9b02c7-1036-4448-87b9-3a22b572c01212022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1627FYLNETRA (PEGFILGRASTIM) INJECTION [AMNEAL PHARMACEUTICALS LLC]8Current NDC, Legacy NDC, 2 package rows20250509_eeadd641-573d-47fe-897a-61006e5f9e03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2602787Fylnetra 6 MG in 0.6 ML Prefilled SyringePSNeeadd641-573d-47fe-897a-61006e5f9e038
2602781pegfilgrastim-pbbk 6 MG in 0.6 ML Prefilled SyringePSNeeadd641-573d-47fe-897a-61006e5f9e038
26027870.6 ML pegfilgrastim-pbbk 10 MG/ML Prefilled Syringe [Fylnetra]SBDeeadd641-573d-47fe-897a-61006e5f9e038
26027810.6 ML pegfilgrastim-pbbk 10 MG/ML Prefilled SyringeSCDeeadd641-573d-47fe-897a-61006e5f9e038
2602787Fylnetra 10 MG/ML per 0.6 ML Prefilled SyringeSYeeadd641-573d-47fe-897a-61006e5f9e038
2602787Fylnetra 6 MG per 0.6 ML Prefilled SyringeSYeeadd641-573d-47fe-897a-61006e5f9e038
2602781pegfilgrastim-pbbk 10 MG/ML per 0.6 ML Prefilled SyringeSYeeadd641-573d-47fe-897a-61006e5f9e038
2602781pegfilgrastim-pbbk 6 MG per 0.6 ML Prefilled SyringeSYeeadd641-573d-47fe-897a-61006e5f9e038

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1627-1701211627011 SYRINGE in 1 CARTON (70121-1627-1) / .6 mL in 1 SYRINGE1 syringe2022-05-310000-00-00NoNoCurrent