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 12 of 54 · 1,068 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Northwest Regional 1019NORTHWEST REGIONALProfessional Complementary Health Formulas4dccc9f6-4d9e-4eec-b031-1fccdddb3d032026-01-08WarningsExact identifier
unii: 451W47IQ8X
Headache Drops 2027HEADACHE DROPSProfessional Complementary Health Formulasa7e345fb-c4aa-4b10-8074-9d8c373041422026-01-08WarningsExact identifier
unii: 451W47IQ8X
Metab 6012METABProfessional Complementary Health Formulasf3576d6f-c9ab-4370-8a32-b6c4bf6ba4fd2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Cell Salt Combination 8013CELL SALT COMBINATIONProfessional Complementary Health Formulasb3a33345-3c3d-4f86-ae4d-757c65fd1ed32026-01-08WarningsExact identifier
unii: 451W47IQ8X
Shingles Nosode 4028SHINGLES NOSODEProfessional Complementary Health Formulase71d917a-af9f-41e9-a3de-cb588db7e0222026-01-08WarningsExact identifier
unii: 451W47IQ8X
Immune System Stimulator Drops 2033IMMUNE SYSTEM STIMULATOR DROPSProfessional Complementary Health Formulasf4595c63-1c9c-48a6-a13a-3659991f455b2026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Gallbladder 7007RET GALLBLADDERProfessional Complementary Health Formulas82bc7b50-aea3-4993-b171-919940fef2972026-01-08WarningsExact identifier
unii: 451W47IQ8X
Libido Stim Liquescence 3014LIBIDO STIM LIQUESCENCEProfessional Complementary Health Formulas3d59b77d-817b-4021-a6dd-75d3b4b608662026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Pituitary/Sex 7012RET PITUITARY/SEXProfessional Complementary Health Formulas5081185c-1598-4bf5-b47b-b15135c453fb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Melancholy Drops Extrovert 2015MELANCHOLY DROPS EXTROVERTProfessional Complementary Health Formulas2c9187ce-a52e-445e-a36e-fe374f5ad2e22026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Lung 7003RET LUNGProfessional Complementary Health Formulas2ed03832-f226-4b3c-9ee6-5352f8d79fdb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Melancholy Drops Introvert 2016MELANCHOLY DROPS INTROVERTProfessional Complementary Health Formulas60e305b4-bb1f-465e-963d-38e6b38df98d2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Spleen Stim Liquescence 3028SPLEEN STIM LIQUESCENCEProfessional Complementary Health Formulas463b62a5-4d4f-445f-ba24-859195730cab2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Melancholy Drops 2002MELANCHOLY DROPSProfessional Complementary Health Formulas96d7f202-c19b-4914-96bb-9906ad781ad02026-01-08WarningsExact identifier
unii: 451W47IQ8X
Natrum Muriaticum 8009NATRUM MURIATICUMProfessional Complementary Health Formulasb4a48b58-28c0-4368-83e8-40ce52ae5f2b2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Aletris Combination 9203ALETRIS COMBINATIONProfessional Complementary Health Formulas87ae7310-927b-48fe-b659-6f93dad623632026-01-08WarningsExact identifier
unii: 451W47IQ8X
Fertility Drops 2174FERTILITY DROPSProfessional Complementary Health Formulas78985992-bb47-4045-82f3-a6094e48d50a2026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Liver 7008RET LIVERProfessional Complementary Health Formulasd81bdbbd-5cfa-40e3-99f5-fd5368239fbe2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Herbal Diuretic Liquescence 3011HERBAL DIURETIC LIQUESCENCEProfessional Complementary Health Formulas5eee7f21-a3c4-46e0-a642-a4ca635734e32026-01-08WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEBECTON DICKINSON AND COMPANYd39b7307-df67-4e68-acb0-2eda5dc612152026-01-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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