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 Identifiers#

Field, Values table
FieldValues
Unii3A58010674
Rxcui2613763, 2613769

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

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