FDA.reportPublic FDA data

Neulasta

Product NDC
55513-099
11-digit product format
555130099
Labeler code
55513
Product ID
55513-099_0a35b49f-339b-4651-829a-4e84fb3a0759
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pegfilgrastim
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Labeler
Amgen, Inc
Application
BLA125031
Marketing category
BLA
Marketing start
2026-03-31
Substance
PEGFILGRASTIM
Active strength
4 mg/.4mL
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
Neulasta
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEGFILGRASTIM4 mg/.4mL

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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
727539Internal RxNorm lookup
727542Internal RxNorm lookup
2549331Internal RxNorm lookup
2549333Internal RxNorm lookup
2739503Internal RxNorm lookup
2739504Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fdfe5d72-6b80-435a-afa4-c5d74dd852ceAvailable 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
55513-099-01Neulasta1 in 1 CARTONSOLUTION1159
55513-099-01Neulasta0.4 mL in 1 VIALSOLUTION0.4159

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-099-01ML - Milliliter55513-09958445014-3d9e-41d4-8be8-29bec8ca151912026-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PEGFILGRASTIMACTIVE INGREDIENT3A58010674NEULASTA (PEGFILGRASTIM) KIT NEULASTA (PEGFILGRASTIM) INJECTION [AMGEN INC]126
PEGFILGRASTIMACTIVE MOIETY3A58010674NEULASTA (PEGFILGRASTIM) KIT NEULASTA (PEGFILGRASTIM) INJECTION [AMGEN INC]126
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PNEULASTA (PEGFILGRASTIM) KIT NEULASTA (PEGFILGRASTIM) INJECTION [AMGEN INC]126
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHNEULASTA (PEGFILGRASTIM) KIT NEULASTA (PEGFILGRASTIM) INJECTION [AMGEN INC]126
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INEULASTA (PEGFILGRASTIM) KIT NEULASTA (PEGFILGRASTIM) INJECTION [AMGEN INC]126
SORBITOLINACTIVE INGREDIENT506T60A25RNEULASTA (PEGFILGRASTIM) KIT NEULASTA (PEGFILGRASTIM) INJECTION [AMGEN INC]126
WATERINACTIVE INGREDIENT059QF0KO0RNEULASTA (PEGFILGRASTIM) KIT NEULASTA (PEGFILGRASTIM) INJECTION [AMGEN INC]126

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
NeulastaPEGFILGRASTIMAmgen, Incfdfe5d72-6b80-435a-afa4-c5d74dd852ce2026-03-10Warnings, Adverse reactionsExact identifier
application number: BLA125031
ndc (product): 55513-099

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125031Neulastapegfilgrastim351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2739504Neulasta 4 MG in 0.4 ML InjectionPSNfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
727542Neulasta 6 MG in 0.6 ML Prefilled SyringePSNfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
2549333Neulasta Onpro 6 MG in 0.6 mL InjectionPSNfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
2739503pegfilgrastim 4 MG in 0.4 ML InjectionPSNfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
2549331pegfilgrastim 6 MG in 0.6 mL On-body InjectionPSNfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
727539pegfilgrastim 6 MG in 0.6 ML Prefilled SyringePSNfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
27395040.4 ML pegfilgrastim 10 MG/ML Injection [Neulasta]SBDfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
25493330.6 ML pegfilgrastim 10 MG/ML Injection [Neulasta]SBDfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
7275420.6 ML pegfilgrastim 10 MG/ML Prefilled Syringe [Neulasta]SBDfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
27395030.4 ML pegfilgrastim 10 MG/ML InjectionSCDfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
25493310.6 ML pegfilgrastim 10 MG/ML InjectionSCDfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
7275390.6 ML pegfilgrastim 10 MG/ML Prefilled SyringeSCDfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
7275420.6 ML Neulasta 10 MG/ML Prefilled SyringeSYfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
2739504Neulasta 4 MG per 0.4 ML InjectionSYfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
727542Neulasta 6 MG per 0.6 ML Prefilled SyringeSYfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
2549333Neulasta Onpro 6 MG per 0.6 ML InjectionSYfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
2549331pegfilgrastim 10 MG/ML per 0.6 ML On-body InjectionSYfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
2739503pegfilgrastim 4 MG per 0.4 ML InjectionSYfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
2549331pegfilgrastim 6 MG per 0.6 ML On-body InjectionSYfdfe5d72-6b80-435a-afa4-c5d74dd852ce159
727539pegfilgrastim 6 MG per 0.6 ML Prefilled SyringeSYfdfe5d72-6b80-435a-afa4-c5d74dd852ce159

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55513-099-01555130099011 VIAL in 1 CARTON (55513-099-01) / .4 mL in 1 VIAL1 vial2026-03-31NoNoCurrent