FDA.reportPublic FDA data

NDC 55513-209-01 - 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
55513-209
Requested NDC
55513-209-01
Package NDCs from labels
55513-209-01, 55513-209-10, 55513-209-91, 55513-209-20
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
55513-209-01NEUPOGEN0.8 mL in 1 SYRINGEINJECTION, SOLUTION0.8164
55513-209-10NEUPOGEN10 in 1 BOXINJECTION, SOLUTION10164
55513-209-20NEUPOGEN10 in 1 BOXINJECTION, SOLUTION10164
55513-209-91NEUPOGEN0.8 mL in 1 SYRINGEINJECTION, SOLUTION0.8164
55513-209-91NEUPOGEN1 in 1 BOXINJECTION, SOLUTION1164

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-209NEUPOGEN (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
55513-209-01ML - Milliliter55513-209c3617246-0d6e-4b4a-b403-80015977f49612012-07-24
55513-209-10ML - Milliliter55513-20936e28938-e574-47a9-9413-efa9fa0a940512012-07-24
55513-209-20ML - Milliliter55513-20930bce519-f07e-41f6-8e4c-2aa51ff543fb12026-02-05
55513-209-91ML - Milliliter55513-20915d5c371-7741-4fc1-9d18-8a76fcbb915912014-05-02

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 5 of 13 · 250 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
ZARXIOFILGRASTIM-SNDZSandoz Inc.c0d1c22b-566b-4776-bdbf-00f96dad0cae2025-08-29Warnings, Adverse reactionsExact identifier
unii: PVI5M0M1GW
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NivestymFILGRASTIM-AAFIPfizer Laboratories Div Pfizer Incd23ab39c-b6ec-41cf-a529-9dd2852c9d9a2025-08-12Warnings, Adverse reactionsExact identifier
unii: PVI5M0M1GW
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: Q40Q9N063P
DENTAL-CHORDACETICUM ACIDUM, AMMONIUM MURIATICUM, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARBOLICUM ACIDUM, CITRUS LIMONUM, CUPRUM METALLICUM, FERRUM METALLICUM, GLYCYRRHIZA GLABRA, LAPPA MAJOR, MEDULLA OSSIS SUIS, MERCURIUS SOLUBILIS, MYRRHA, NATRUM FLUORATUM, PALLADIUM METALLICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SELENIUM METALLICUM, SILICEA, STANNUM METALLICUM, STAPHYSAGRIA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, X-RAY, ZINCUM OXYDATUMEnergetix Corporation6c9ba926-7c35-49fd-94d8-988ca0bb772c2025-07-15WarningsExact identifier
unii: Q40Q9N063P
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hydrocortisone and Acetic AcidHYDROCORTISONE AND ACETIC ACIDSun Pharmaceutical Industries, Inc.6383c722-84e2-4719-a13d-19c54e3eefff2025-07-07Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
unii: 506T60A25R
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
NYPOZIFILGRASTIM-TXIDCipla USA Inc.575d164d-45fa-4e3e-81e4-2652d96673d12025-05-01Warnings, Adverse reactionsExact identifier
unii: PVI5M0M1GW

Reported adverse events (FAERS/openFDA)#

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