FDA.reportPublic FDA data

NEUPOGEN

Product NDC
55513-546
11-digit product format
555130546
Labeler code
55513
Product ID
55513-546_52115df1-de31-4353-a33b-5ca065af4e85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Filgrastim
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Amgen, Inc
Application
BLA103353
Marketing category
BLA
Marketing start
1997-04-07
Substance
FILGRASTIM
Active strength
480 ug/1.6mL
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FILGRASTIM480 ug/1.6mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PVI5M0M1GWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
727535Internal RxNorm lookup
727537Internal RxNorm lookup
727544Internal RxNorm lookup
727545Internal RxNorm lookup
1649944Internal RxNorm lookup
1649946Internal RxNorm lookup
1649963Internal RxNorm lookup
1649964Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
97cc73cc-b5b7-458a-a933-77b00523e193Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f366651-2cb6-4932-a760-2ae84fd8fbffProduct name120230703
3b1c6100-f679-4300-94a6-3b3fc05b0c44Product name120230110
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-546-01NEUPOGEN1.6 mL in 1 VIALINJECTION, SOLUTION1.6164
55513-546-10NEUPOGEN10 in 1 BOXINJECTION, SOLUTION10164
55513-546-20NEUPOGEN10 in 1 BOXINJECTION, SOLUTION10164

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-546-01ML - Milliliter55513-546432a83f4-9d08-4117-84ee-a524ffbbae2e12012-07-24
55513-546-10ML - Milliliter55513-546f0301283-9080-443b-bc23-e90f95a4c98712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FILGRASTIM, LICENSE HOLDER UNSPECIFIEDACTIVE INGREDIENTPVI5M0M1GWNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]144
FILGRASTIM, LICENSE HOLDER UNSPECIFIEDACTIVE MOIETYPVI5M0M1GWNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]144
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]144
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]144
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]144
SORBITOLINACTIVE INGREDIENT506T60A25RNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]144
WATERINACTIVE INGREDIENT059QF0KO0RNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-546NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN, INC]162Current NDC, Legacy NDC, 3 package rows20250503_97cc73cc-b5b7-458a-a933-77b00523e193.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
NEUPOGENFILGRASTIMAmgen, Inc97cc73cc-b5b7-458a-a933-77b00523e1932026-07-23Warnings, Adverse reactionsExact identifier
application number: BLA103353
ndc (product): 55513-546

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103353Neupogenfilgrastim351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727535filgrastim 300 MCG in 0.5 ML Prefilled SyringePSN97cc73cc-b5b7-458a-a933-77b00523e193164
1649944filgrastim 300 MCG in 1 ML InjectionPSN97cc73cc-b5b7-458a-a933-77b00523e193164
727544filgrastim 480 MCG in 0.8 ML Prefilled SyringePSN97cc73cc-b5b7-458a-a933-77b00523e193164
1649963filgrastim 480 MCG in 1.6 ML InjectionPSN97cc73cc-b5b7-458a-a933-77b00523e193164
727537Neupogen 300 MCG in 0.5 ML Prefilled SyringePSN97cc73cc-b5b7-458a-a933-77b00523e193164
1649946Neupogen 300 MCG in 1 ML InjectionPSN97cc73cc-b5b7-458a-a933-77b00523e193164
727545Neupogen 480 MCG in 0.8 ML Prefilled SyringePSN97cc73cc-b5b7-458a-a933-77b00523e193164
1649964Neupogen 480 MCG in 1.6 ML InjectionPSN97cc73cc-b5b7-458a-a933-77b00523e193164
7275370.5 ML filgrastim 0.6 MG/ML Prefilled Syringe [Neupogen]SBD97cc73cc-b5b7-458a-a933-77b00523e193164
7275450.8 ML filgrastim 0.6 MG/ML Prefilled Syringe [Neupogen]SBD97cc73cc-b5b7-458a-a933-77b00523e193164
16499461 ML filgrastim 0.3 MG/ML Injection [Neupogen]SBD97cc73cc-b5b7-458a-a933-77b00523e193164
16499641.6 ML filgrastim 0.3 MG/ML Injection [Neupogen]SBD97cc73cc-b5b7-458a-a933-77b00523e193164
7275350.5 ML filgrastim 0.6 MG/ML Prefilled SyringeSCD97cc73cc-b5b7-458a-a933-77b00523e193164
7275440.8 ML filgrastim 0.6 MG/ML Prefilled SyringeSCD97cc73cc-b5b7-458a-a933-77b00523e193164
16499441 ML filgrastim 0.3 MG/ML InjectionSCD97cc73cc-b5b7-458a-a933-77b00523e193164
16499631.6 ML filgrastim 0.3 MG/ML InjectionSCD97cc73cc-b5b7-458a-a933-77b00523e193164
7275370.5 ML Neupogen 0.6 MG/ML Prefilled SyringeSY97cc73cc-b5b7-458a-a933-77b00523e193164
7275450.8 ML Neupogen 0.6 MG/ML Prefilled SyringeSY97cc73cc-b5b7-458a-a933-77b00523e193164
16499461 ML Neupogen 0.3 MG/ML InjectionSY97cc73cc-b5b7-458a-a933-77b00523e193164
16499641.6 ML Neupogen 0.3 MG/ML InjectionSY97cc73cc-b5b7-458a-a933-77b00523e193164
727535filgrastim 0.3 MG per 0.5 ML Prefilled SyringeSY97cc73cc-b5b7-458a-a933-77b00523e193164
727544filgrastim 0.48 MG per 0.8 ML Prefilled SyringeSY97cc73cc-b5b7-458a-a933-77b00523e193164
727535filgrastim 300 MCG per 0.5 ML Prefilled SyringeSY97cc73cc-b5b7-458a-a933-77b00523e193164
1649944filgrastim 300 MCG per 1 ML InjectionSY97cc73cc-b5b7-458a-a933-77b00523e193164
727544filgrastim 480 MCG per 0.8 ML Prefilled SyringeSY97cc73cc-b5b7-458a-a933-77b00523e193164
1649963filgrastim 480 MCG per 1.6 ML InjectionSY97cc73cc-b5b7-458a-a933-77b00523e193164
727537Neupogen 300 MCG per 0.5 ML Prefilled SyringeSY97cc73cc-b5b7-458a-a933-77b00523e193164
1649946Neupogen 300 MCG per 1 ML InjectionSY97cc73cc-b5b7-458a-a933-77b00523e193164
727545Neupogen 480 MCG per 0.8 ML Prefilled SyringeSY97cc73cc-b5b7-458a-a933-77b00523e193164
1649964Neupogen 480 MCG per 1.6 ML InjectionSY97cc73cc-b5b7-458a-a933-77b00523e193164

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55513-546-01555130546011.6 mL in 1 VIAL1.6 mlHistorical
55513-546-105551305461010 VIAL in 1 BOX (55513-546-10) / 1.6 mL in 1 VIAL (55513-546-01) 10 vial1997-04-070000-00-00NoNoCurrent
55513-546-205551305462010 VIAL in 1 BOX (55513-546-20) / 1.6 mL in 1 VIAL (55513-546-01) 10 vial2025-10-01NoNoCurrent