FDA.reportPublic FDA data

NDC 55513-924-01 - NEUPOGEN

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
55513-924
Requested NDC
55513-924-01
Package NDCs from labels
55513-924-01, 55513-924-10, 55513-924-91, 55513-924-20
Manufacturer
Amgen, Inc | Amgen Manufacturing Limited LLC
Effective date
2026-07-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NEUPOGEN - Amgen, Inc | Amgen Manufacturing Limited LLCAmgen, Inc | Amgen Manufacturing Limited LLC2026-07-23HUMAN PRESCRIPTION DRUG LABEL
Neupogen - Physicians Total Care, Inc.Physicians Total Care, Inc.2009-12-02HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-924-01NEUPOGEN0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.5164
55513-924-10NEUPOGEN10 in 1 BOXINJECTION, SOLUTION10164
55513-924-20NEUPOGEN10 in 1 BOXINJECTION, SOLUTION10164
55513-924-91NEUPOGEN1 in 1 BOXINJECTION, SOLUTION1164
55513-924-91NEUPOGEN0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.5164

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-924NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN, INC]162Current NDC, Legacy NDC, 5 package rows20250503_97cc73cc-b5b7-458a-a933-77b00523e193.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-924-01ML - Milliliter55513-924c9c288d1-e31f-45a9-85ce-5569fbbefdd712012-07-24
55513-924-10ML - Milliliter55513-924700e725f-c00e-4e16-8414-3f59b856929d12012-07-24
55513-924-91ML - Milliliter55513-924bb4f96fd-54bc-408b-85e1-25ae491d36fb12014-05-02

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
FILGRASTIMACTIVE INGREDIENTPVI5M0M1GWNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
FILGRASTIMACTIVE MOIETYPVI5M0M1GWNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM POLYMETAPHOSPHATEINACTIVE INGREDIENTP1BM4ZH95LNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1

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 13 · 251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: Q40Q9N063P
Medi-ChordHOMEOPATHIC LIQUIDEnergetix Corporation57bc618b-15bd-4d04-8037-fb192e743e302026-08-11WarningsExact identifier
unii: Q40Q9N063P
Thyro-ChordHOMEOPATHIC LIQUIDEnergetix Corporation6655b504-dfa8-46df-9d3a-b7fa4078207e2026-08-11WarningsExact identifier
unii: Q40Q9N063P
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
NEUPOGENFILGRASTIMAmgen, Inc97cc73cc-b5b7-458a-a933-77b00523e1932026-07-23Warnings, Adverse reactionsExact identifier
application number: BLA103353
ndc (package): 55513-530-01
ndc (package): 55513-209-20
ndc (package): 55513-924-01
ndc (package): 55513-924-10
ndc (package): 55513-924-20
ndc (package): 55513-209-91
ndc (package): 55513-546-10
ndc (package): 55513-530-10
ndc (package): 55513-209-10
ndc (package): 55513-546-20
ndc (package): 55513-530-20
ndc (package): 55513-209-01
ndc (package): 55513-924-91
ndc (package): 55513-546-01
ndc (product): 55513-546
ndc (product): 55513-924
ndc (product): 55513-209
ndc (product): 55513-530
ndc11 (package): 55513092401
rxcui: 1649964
rxcui: 727537
rxcui: 727544
rxcui: 1649946
rxcui: 727545
rxcui: 1649963
rxcui: 1649944
rxcui: 727535
spl id: 7cedb5f4-cfdd-46a5-836d-e5384c65a224
spl set id: 97cc73cc-b5b7-458a-a933-77b00523e193
unii: PVI5M0M1GW
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FILKRIFILGRASTIM-LAHAAccord BioPharma Inc.,9c2f9573-08fd-43be-a489-8a5e5d8ab2ff2026-07-10Warnings, Adverse reactionsExact identifier
unii: PVI5M0M1GW
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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