FDA.reportPublic FDA data

FYLNETRA

Product NDC
70121-1627
Requested package NDC
70121-1627-1
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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3A58010674Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2602781Internal RxNorm lookup
2602787Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eeadd641-573d-47fe-897a-61006e5f9e03Available on FDA.report

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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FYLNETRAPEGFILGRASTIMAmneal Pharmaceuticals LLCeeadd641-573d-47fe-897a-61006e5f9e032025-04-25Warnings, Adverse reactionsExact identifier
application number: BLA761084
ndc (package): 70121-1627-1
ndc (product): 70121-1627
ndc11 (package): 70121162701

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761084Fylnetrapegfilgrastim-pbbk351(k) BiosimilarRx2026-07-01

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