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 4 of 13 · 250 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 506T60A25R
SKIN TAG REMOVERSALICYLIC ACIDShenzhen Yaozhihong Technology Co., Ltd.4246d4d5-9955-ba5a-e063-6394a90a84482025-10-29WarningsExact identifier
unii: Q40Q9N063P
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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