FDA.reportPublic FDA data

STIMUFEND

Product NDC
65219-371
11-digit product format
652190371
Labeler code
65219
Product ID
65219-371_90fa8a88-1bd6-49cf-a482-ccbc0d315b3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pegflilgrastim-fpgk
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
BLA761173
Marketing category
BLA
Marketing start
2022-10-06
Substance
PEGFILGRASTIM
Active strength
6 mg/.6mL
Pharmacologic classes
Granulocyte Colony-Stimulating Factor [CS], Granulocyte-Macrophage 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
STIMUFEND
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
2613763Internal RxNorm lookup
2613769Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b44bcb82-7e60-4dab-a658-115bdf5c053cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
7979a9c8-e75a-40a9-87cc-a5f08355aaefProduct name120230626
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c3bb58c9-5c71-4b39-a70d-70acbffd3efeProduct name120230127
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
4217ae0d-ff4c-46f5-9e69-8cb4b72b3e37Product name120150402
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-371-10STIMUFEND1 in 1 CARTONINJECTION, SOLUTION14
65219-371-10STIMUFEND1 in 1 BLISTER PACKINJECTION, SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-371-10ML - Milliliter65219-3711ff481c6-4b1a-4e12-95c1-f12ceffdb68b12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-371STIMUFEND (PEGFLILGRASTIM-FPGK) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20231026_b44bcb82-7e60-4dab-a658-115bdf5c053c.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STIMUFENDPEGFLILGRASTIM-FPGKNORTHSTAR RX LLC1e36ee55-7f13-41db-9d49-2f7a92f3b7502025-11-30Warnings, Adverse reactionsExact identifier
application number: BLA761173
STIMUFENDPEGFLILGRASTIM-FPGKFresenius Kabi USA, LLCb44bcb82-7e60-4dab-a658-115bdf5c053c2023-10-24Warnings, Adverse reactionsExact identifier
application number: BLA761173
ndc (product): 65219-371

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761173Stimufendpegfilgrastim-fpgk351(k) BiosimilarRx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2613763pegfilgrastim-fpgk 6 MG in 0.6 ML Prefilled SyringePSNb44bcb82-7e60-4dab-a658-115bdf5c053c4
2613769Stimufend 6 MG in 0.6 ML Prefilled SyringePSNb44bcb82-7e60-4dab-a658-115bdf5c053c4
26137690.6 ML pegfilgrastim-fpgk 10 MG/ML Prefilled Syringe [Stimufend]SBDb44bcb82-7e60-4dab-a658-115bdf5c053c4
26137630.6 ML pegfilgrastim-fpgk 10 MG/ML Prefilled SyringeSCDb44bcb82-7e60-4dab-a658-115bdf5c053c4
26137690.6 ML Stimufend 10 MG/ML Prefilled SyringeSYb44bcb82-7e60-4dab-a658-115bdf5c053c4
2613763pegfilgrastim-fpgk 6 MG per 0.6 ML Prefilled SyringeSYb44bcb82-7e60-4dab-a658-115bdf5c053c4
2613769Stimufend 6 MG per 0.6 ML Prefilled SyringeSYb44bcb82-7e60-4dab-a658-115bdf5c053c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65219-371-10652190371101 BLISTER PACK in 1 CARTON (65219-371-10) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE1 blister pack2022-10-060000-00-00NoNoCurrent