FDA.reportPublic FDA data

NDC 55513-005-01 - ARANESP

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
55513-005
Requested NDC
55513-005-01
Package NDCs from labels
55513-005-01, 55513-005-04
Manufacturer
Amgen, Inc | Amgen Manufacturing Limited LLC
Effective date
2026-07-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ARANESP - Amgen, Inc | Amgen Manufacturing Limited LLCAmgen, Inc | Amgen Manufacturing Limited LLC2026-07-07HUMAN 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
55513-005-01ARANESP1 mL in 1 VIAL, SINGLE-DOSESOLUTION1159
55513-005-04ARANESP4 in 1 PACKAGESOLUTION4159

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-005ARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]157Current NDC, Legacy NDC, 2 package rows20240530_0fd36cb9-c4f6-4167-93c9-8530865db3f9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-005-01ML - Milliliter55513-005e43ab8a3-1ed9-48bb-8924-b28e59cf773312012-07-24
55513-005-04ML - Milliliter55513-0052f5e95b4-3fc4-45a3-8a1a-ad1c15b3907612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DARBEPOETIN ALFAACTIVE INGREDIENT15UQ94PT4PARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]138
DARBEPOETIN ALFAACTIVE MOIETY15UQ94PT4PARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]138
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]138
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]138
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]138
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]138
WATERINACTIVE INGREDIENT059QF0KO0RARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]138

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 3 of 54 · 1,068 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
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
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X
ARANESPDARBEPOETIN ALFAAmgen, Inc0fd36cb9-c4f6-4167-93c9-8530865db3f92026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103951
ndc (package): 55513-025-01
ndc (package): 55513-028-01
ndc (package): 55513-032-01
ndc (package): 55513-027-01
ndc (package): 55513-006-01
ndc (package): 55513-027-04
ndc (package): 55513-004-01
ndc (package): 55513-002-01
ndc (package): 55513-021-04
ndc (package): 55513-023-01
ndc (package): 55513-023-04
ndc (package): 55513-003-04
ndc (package): 55513-006-21
ndc (package): 55513-005-04
ndc (package): 55513-005-01
ndc (package): 55513-057-01
ndc (package): 55513-098-04
ndc (package): 55513-057-04
ndc (package): 55513-003-01
ndc (package): 55513-002-04
ndc (package): 55513-025-04
ndc (package): 55513-021-01
ndc (package): 55513-004-04
ndc (package): 55513-098-01
ndc (package): 55513-111-01
ndc (product): 55513-023
ndc (product): 55513-025
ndc (product): 55513-111
ndc (product): 55513-004
ndc (product): 55513-098
ndc (product): 55513-003
ndc (product): 55513-028
ndc (product): 55513-005
ndc (product): 55513-002
ndc (product): 55513-032
ndc (product): 55513-021
ndc (product): 55513-057
ndc (product): 55513-027
ndc (product): 55513-006
ndc11 (package): 55513000501
rxcui: 1605172
rxcui: 349273
rxcui: 731235
rxcui: 1654954
rxcui: 349275
rxcui: 731174
rxcui: 731250
rxcui: 731167
rxcui: 730046
rxcui: 731171
rxcui: 731231
rxcui: 731227
rxcui: 352044
rxcui: 731179
rxcui: 352046
rxcui: 731181
rxcui: 1605171
rxcui: 731229
rxcui: 1654955
rxcui: 352045
rxcui: 349276
rxcui: 731245
rxcui: 731184
rxcui: 349274
rxcui: 352047
rxcui: 730044
rxcui: 731241
rxcui: 731176
spl id: 2f0f60a5-832a-4954-ba26-7dec84fcf4f3
spl set id: 0fd36cb9-c4f6-4167-93c9-8530865db3f9
unii: 15UQ94PT4P
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
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.