NDC 55513-478-01 - EPOGEN

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
55513-478
Requested NDC
55513-478-01
Package NDCs from labels
55513-478-01, 55513-478-10, 55513-478-20
Manufacturer
Amgen, Inc | Amgen Manufacturing Limited LLC
Effective date
2026-06-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
EPOGEN - Amgen, Inc | Amgen Manufacturing Limited LLCAmgen, Inc | Amgen Manufacturing Limited LLC2026-06-23HUMAN 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
55513-478-01EPOGEN1 mL in 1 VIALSOLUTION1136
55513-478-10EPOGEN10 in 1 PACKAGESOLUTION10136
55513-478-20EPOGEN10 in 1 PACKAGESOLUTION10136

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-478EPOGEN (EPOETIN ALFA) SOLUTION [AMGEN INC]135Current NDC, Legacy NDC, 3 package rows20250425_1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-478-01ML - Milliliter55513-47807d24d62-938f-474d-9fc8-7e21bb3eef2f12012-07-24
55513-478-10ML - Milliliter55513-4788ff35cb7-d870-40e6-bb9b-3e24d38d65b512012-07-24
55513-478-20ML - Milliliter55513-478c98b500f-a3f7-4e70-92c0-216b06250a4112026-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ERYTHROPOIETINACTIVE INGREDIENT64FS3BFH5WEPOGEN (EPOETIN ALFA) SOLUTION [AMGEN INC]121
ERYTHROPOIETINACTIVE MOIETY64FS3BFH5WEPOGEN (EPOETIN ALFA) SOLUTION [AMGEN INC]121
ALBUMIN HUMANINACTIVE INGREDIENTZIF514RVZREPOGEN (EPOETIN ALFA) SOLUTION [AMGEN INC]121
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHEPOGEN (EPOETIN ALFA) SOLUTION [AMGEN INC]121
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPEPOGEN (EPOETIN ALFA) SOLUTION [AMGEN INC]121
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XEPOGEN (EPOETIN ALFA) SOLUTION [AMGEN INC]121
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULREPOGEN (EPOETIN ALFA) SOLUTION [AMGEN INC]121
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FEPOGEN (EPOETIN ALFA) SOLUTION [AMGEN INC]121
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNEPOGEN (EPOETIN ALFA) SOLUTION [AMGEN INC]121

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 8 of 48 · 951 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Constitutional EnhancerACONITUM NAPELLUS, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA, CALCAREA CARBONICA, CANTHARIS, GELSEMIUM SEMPERVIRENS, GRAPHITES, HYDRASTIS CANADENSIS, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOX, SEPIA, SILICEA AND SULPHUR.King Bio Inc.448becd7-58aa-40ae-9b4b-39f48a8f13dd2026-03-10WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.018a8807-1331-41c3-4889-c7ec502a90432026-03-09Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Headache and Migraine ReliefBELLADONNA, BRYONIA, CAPSICUM ANNUUM, GELSEMIUM, GLONOINUM, IGNATIA AMARA, KALI BICHROMICUM, KALI CARBONICUM, LYCOPODIUM, NATRUM MURIATICUM, NICCOLUM METALLICUM, NUX VOMICA, SANGUINARIA, SECALE CORNUTUM, SPIGELIA ANTH AND SULPHUR.King Bio Inc.efbfd58c-f3a6-4734-a37f-9f58fded990a2026-03-06WarningsExact identifier
unii: 451W47IQ8X
Walgreens Unscented Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLWalgreen Co.41eadb4f-2ca5-42a1-e063-6294a90ab4e22026-03-04WarningsExact identifier
unii: LKG8494WBH
Grain and WheatADRENALINUM, AVENA SATIVA, BRYONIA (ALBA), GLYCINE MAX (SOY), HISTAMINUM HYDROCHLORICUM, BARLEY, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RYE, WHEAT, CORNNaturalCare3bd8e473-9aac-4a0c-9117-1f1488a75b7b2026-03-03WarningsExact identifier
unii: 451W47IQ8X
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare75648609-288c-4988-8b96-46f52d639bd32026-03-03WarningsExact identifier
unii: 451W47IQ8X
Allergy Relief Indoor and OutdoorALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARUM TRIPHYLLUM, ARUNDO MAURITANICA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, NAPHTHALINUM, NATRUM MURIATICUM, SABADILLA, SOLIDAGO VIRGAUREA, STICTA PULMONARIA, SULPHUR, TRIFOLIUM PRATENSE, AND WYETHIA HELENIOIDES.King Bio Inc.9faa963e-4ddc-461f-95a1-2d10e12606122026-03-02WarningsExact identifier
unii: 451W47IQ8X
LibidotoneARALIA QUINQUEFOLIA, BERBERIS VULGARIS, AGNUS CASTUS, AVENA SATIVA, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, HYPOPHYSIS SUIS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, SEPIAEnergique, Inc.4ceacaa0-0219-421a-8fff-c1784c3d0f702026-02-27WarningsExact identifier
unii: 451W47IQ8X
911 Adrenal Burnout and FatigueACETICUM AC, ADRENALINUM, ADRENOCORTICOTROPHIN (30X), AESCULUS HIPPOCASTANUM, FLOS, ALFALFA, ALPHA-LIPOIC AC, AMBRA, ARG NIT, AVENA SATIVA, BRYONIA, CARBONEUM OXYGENISATUM, CARPINUS BETULUS, FLOS, DNA, FUMARICUM ACIDUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS, KALI PHOSPHORICUM, LACTICUM ACIDUM, LECITHIN, NATRUM MURIATICUM, OXALICUM ACIDUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SEPIA, SILICEA, SUCCINICUM ACIDUM AND THYROIDINUM.King Bio Inc.21c6b6c1-e846-4f25-a1dc-02e79d1be7562026-02-26WarningsExact identifier
unii: 451W47IQ8X
Oimmal Gentle Eye WashSODIUM CHLORIDEShenzhen Shandian Jingling Technology Co., Ltd.4bb4e59b-a43e-fa38-e063-6294a90aea712026-02-26WarningsExact identifier
unii: 451W47IQ8X
sodium chlorideSODIUM CHLORIDEMedefil, Inc.d1468c0f-dd4f-4d38-a84c-c1d1103039652026-02-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ResentmentADRENALINUM, AMMONIUM MURIATICUM, APOCYNUM CANNABINUM, BUTHUS AUSTRALIS, CARDUUS MARIANUS, CINCHONA OFFICINALIS, FEL TAURI, HEPAR SUIS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS SUIS, MANGANUM CARBONICUM, MOSCHUS, NAJA TRIPUDIANS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, RHUS TOX, TARAXACUM OFFICINALEDeseret Biologicals, Inc.f42e08d9-349e-4e53-802c-175cf17f3f2c2026-02-26WarningsExact identifier
unii: 451W47IQ8X
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC.fd57a176-7faf-4053-b348-6ba5f192f05a2026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Anti-Itch Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, HYPERICUM PERFORATUM WHOLE, AND SODIUM CHLORIDEForces of Nature6131d921-c772-4684-b9ea-c5c8923daaf02026-02-25WarningsExact identifier
unii: 451W47IQ8X
BM BIO28 (General Tonic)CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited38d2cff0-3550-b119-e063-6394a90a31cb2026-02-23WarningsExact identifier
unii: 451W47IQ8X
Allergy KidsURTICA DIOICA LEAF, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND ALTHAEA OFFICINALIS ROOTForces of Nature4886109c-dd7d-40c0-911f-5f12343d8e632026-02-20WarningsExact identifier
unii: 451W47IQ8X
Allergy Maximum StrengthURTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature122ca23e-43f1-4e5c-afc2-1418b17176792026-02-20WarningsExact identifier
unii: 451W47IQ8X
Back Pain Pain ManagementARNICA MONTANA, HORSE CHESTNUT, HYPERICUM PERFORATUM, RUTA GRAVEOLENS WHOLE, AND SODIUM CHLORIDEForces of Naturebf089347-f334-4d6d-ab58-cf7f0b16810f2026-02-20WarningsExact identifier
unii: 451W47IQ8X
RHODODIUMACTEA RACEMOSA, APIS MELL, CALC CARB, GRAPHITES, IODIUM, NATRUM MUR, PULSATILLA, RHODODENDRONBM Private Limited3b3bcba2-6f9e-cd94-e063-6394a90a77012026-02-15WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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