FDA.reportPublic FDA data

Neulasta

Product NDC
55513-190
Requested package NDC
55513-190-01
11-digit product format
555130190
Labeler code
55513
Product ID
55513-190_d8d3175c-3a6d-4bbe-bfd5-3cb352d1669d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pegfilgrastim
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Amgen, Inc
Application
BLA125031
Marketing category
BLA
Marketing start
2002-04-01
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Neulasta
Listing expiration
2027-12-31

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 · 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
55513-190-01Neulasta1 in 1 CARTONINJECTION1159
55513-190-01Neulasta0.6 mL in 1 SYRINGEINJECTION0.6159

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-190-01ML - Milliliter55513-1904b57393a-562d-494f-a2a0-bc461177834f12012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-190NEULASTA (PEGFILGRASTIM) KIT NEULASTA (PEGFILGRASTIM) INJECTION [AMGEN INC]155Current NDC, Legacy NDC, 2 package rows20250418_fdfe5d72-6b80-435a-afa4-c5d74dd852ce.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125031Neulastapegfilgrastim351(a)Rx2026-10-01

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 startMarketing endSampleExclude flagStatus
55513-190-01555130190011 SYRINGE in 1 CARTON (55513-190-01) / .6 mL in 1 SYRINGE1 syringe2002-04-010000-00-00NoNoCurrent