FDA.reportPublic FDA data

EPOGEN

Product NDC
55513-267
11-digit product format
555130267
Labeler code
55513
Product ID
55513-267_79ccf986-8ff8-4318-9a40-4c5d9f3ae9fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
epoetin alfa
Dosage form
SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Amgen, Inc
Application
BLA103234
Marketing category
BLA
Marketing start
1990-04-30
Substance
EPOETIN
Active strength
3000 [iU]/mL
Pharmacologic classes
Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EPOGENEPOETIN ALFAAmgen, Inc1f2d0b28-9cc5-4523-80b8-637fdaf3f7a52026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103234
ndc (product): 55513-267
PROCRITERYTHROPOIETINJanssen Products, LP0c721ba4-ae19-417f-aae1-221ed1a0866a2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103234

Additional Listing Data#

Finished product
Yes
Brand name base
EPOGEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPOETIN3000 [iU]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
64FS3BFH5WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205912Internal RxNorm lookup
205917Internal RxNorm lookup
205921Internal RxNorm lookup
205923Internal RxNorm lookup
212218Internal RxNorm lookup
239998Internal RxNorm lookup
239999Internal RxNorm lookup
240000Internal RxNorm lookup
240377Internal RxNorm lookup
241999Internal RxNorm lookup
1721684Internal RxNorm lookup
1721685Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-267-01EPOGEN1 mL in 1 VIALSOLUTION1136
55513-267-10EPOGEN10 in 1 PACKAGESOLUTION10136
55513-267-20EPOGEN10 in 1 PACKAGESOLUTION10136

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-267-01ML - Milliliter55513-26724e6c25c-524a-4972-8f98-22b9215d2f7512012-07-24
55513-267-10ML - Milliliter55513-267ff7b70e5-0a60-4eb3-9efe-5d01a5d4dd9412012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-267EPOGEN (EPOETIN ALFA) SOLUTION [AMGEN INC]135Current NDC, Legacy NDC, 3 package rows20250425_1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103234Epogen/Procritepoetin alfa351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721684epoetin alfa 10,000 UNT in 1 ML InjectionPSN1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
240000epoetin alfa 10,000 UNT/ML Injectable SolutionPSN1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
241999epoetin alfa 20,000 UNT/ML Injectable SolutionPSN1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
239998epoetin alfa 2000 UNT in 1 ML InjectionPSN1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
240377epoetin alfa 3000 UNT in 1 ML InjectionPSN1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
239999epoetin alfa 4000 UNT in 1 ML InjectionPSN1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
1721685EPOGEN 10,000 UNT in 1 ML InjectionPSN1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
205912EPOGEN 10,000 UNT/ML Injectable SolutionPSN1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
212218EPOGEN 20,000 UNT/ML Injectable SolutionPSN1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
205917EPOGEN 2000 UNT in 1 ML InjectionPSN1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
205921EPOGEN 3000 UNT in 1 ML InjectionPSN1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
205923EPOGEN 4000 UNT in 1 ML InjectionPSN1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
17216851 ML epoetin alfa 10000 UNT/ML Injection [Epogen]SBD1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2059171 ML epoetin alfa 2000 UNT/ML Injection [Epogen]SBD1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2059211 ML epoetin alfa 3000 UNT/ML Injection [Epogen]SBD1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2059231 ML epoetin alfa 4000 UNT/ML Injection [Epogen]SBD1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
205912epoetin alfa 10000 UNT/ML Injectable Solution [Epogen]SBD1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
212218epoetin alfa 20000 UNT/ML Injectable Solution [Epogen]SBD1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
17216841 ML epoetin alfa 10000 UNT/ML InjectionSCD1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2399981 ML epoetin alfa 2000 UNT/ML InjectionSCD1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2403771 ML epoetin alfa 3000 UNT/ML InjectionSCD1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2399991 ML epoetin alfa 4000 UNT/ML InjectionSCD1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
240000epoetin alfa 10000 UNT/ML Injectable SolutionSCD1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
241999epoetin alfa 20000 UNT/ML Injectable SolutionSCD1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
17216841 ML EPO 10000 UNT/ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
17216851 ML EPO 10000 UNT/ML Injection [Epogen]SY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2399981 ML EPO 2000 UNT/ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2059171 ML EPO 2000 UNT/ML Injection [Epogen]SY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2403771 ML EPO 3000 UNT/ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2059211 ML EPO 3000 UNT/ML Injection [Epogen]SY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2399991 ML EPO 4000 UNT/ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2059231 ML EPO 4000 UNT/ML Injection [Epogen]SY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
17216851 ML Epogen 10000 UNT/ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2059171 ML Epogen 2000 UNT/ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2059211 ML Epogen 3000 UNT/ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2059231 ML Epogen 4000 UNT/ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
17216841 ML ERYTHROPOIETIN 10000 UNT/ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
17216851 ML ERYTHROPOIETIN 10000 UNT/ML Injection [Epogen]SY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2399981 ML ERYTHROPOIETIN 2000 UNT/ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2059171 ML ERYTHROPOIETIN 2000 UNT/ML Injection [Epogen]SY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2403771 ML ERYTHROPOIETIN 3000 UNT/ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2059211 ML ERYTHROPOIETIN 3000 UNT/ML Injection [Epogen]SY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2399991 ML ERYTHROPOIETIN 4000 UNT/ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
2059231 ML ERYTHROPOIETIN 4000 UNT/ML Injection [Epogen]SY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
240000EPO 10000 UNT/ML Injectable SolutionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
205912EPO 10000 UNT/ML Injectable Solution [Epogen]SY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
241999EPO 20000 UNT/ML Injectable SolutionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
212218EPO 20000 UNT/ML Injectable Solution [Epogen]SY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
1721684epoetin alfa 10,000 UNT per 1 ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
239998epoetin alfa 2000 UNT per 1 ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
240377epoetin alfa 3000 UNT per 1 ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
239999epoetin alfa 4000 UNT per 1 ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
205912Epogen (epoetin alfa 10,000 UNT/ML) Injectable SolutionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
205912Epogen (epoetin alfa 20,000 UNT per 2 ML) Injectable SolutionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
212218Epogen (epoetin alfa 20,000 UNT/ML) Injectable SolutionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
1721685Epogen 10,000 UNT per 1 ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
205912Epogen 10000 UNT/ML Injectable SolutionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
205917Epogen 2000 UNT per 1 ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
212218Epogen 20000 UNT/ML Injectable SolutionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
205921Epogen 3000 UNT per 1 ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
205923Epogen 4000 UNT per 1 ML InjectionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
240000ERYTHROPOIETIN 10000 UNT/ML Injectable SolutionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
205912ERYTHROPOIETIN 10000 UNT/ML Injectable Solution [Epogen]SY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
241999ERYTHROPOIETIN 20000 UNT/ML Injectable SolutionSY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136
212218ERYTHROPOIETIN 20000 UNT/ML Injectable Solution [Epogen]SY1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5136

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55513-267-01555130267011 mL in 1 VIAL1 mlHistorical
55513-267-105551302671010 VIAL in 1 PACKAGE (55513-267-10) / 1 mL in 1 VIAL (55513-267-01) 10 vial1990-04-300000-00-00NoNoCurrent
55513-267-205551302672010 VIAL in 1 PACKAGE (55513-267-20) / 1 mL in 1 VIAL (55513-267-01) 10 vial2025-04-14NoNoCurrent