FDA.reportPublic FDA data

EPOGEN

Product NDC
55513-126
11-digit product format
555130126
Labeler code
55513
Product ID
55513-126_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
1989-06-30
Substance
EPOETIN
Active strength
2000 [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

Additional Listing Data#

Finished product
Yes
Brand name base
EPOGEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPOETIN2000 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64FS3BFH5W
Rxcui205912, 205917, 205921, 205923, 212218, 239998, 239999, 240000, 240377, 241999, 1721684, 1721685

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
55513-126-01EPOGEN1 mL in 1 VIALSOLUTION1136
55513-126-10EPOGEN10 in 1 PACKAGESOLUTION10136
55513-126-20EPOGEN10 in 1 PACKAGESOLUTION10136

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-126-01ML - Milliliter55513-126f34bb673-0ee0-4ef4-9317-35d59ad7f94f12012-07-24
55513-126-10ML - Milliliter55513-12679796b74-2142-4661-9b8e-ed38021b5c4b12012-07-24
55513-126-20ML - Milliliter55513-126967f978d-ed6f-4940-9fbf-9e6c87d528cb12026-05-22

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
55513-126EPOGEN (EPOETIN ALFA) SOLUTION [AMGEN INC]135Current NDC, Legacy NDC, 3 package rows20250425_1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5.zip

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
55513-126-01555130126011 mL in 1 VIAL1 mlHistorical
55513-126-105551301261010 VIAL in 1 PACKAGE (55513-126-10) / 1 mL in 1 VIAL (55513-126-01) 10 vial1989-06-300000-00-00NoNoCurrent
55513-126-205551301262010 VIAL in 1 PACKAGE (55513-126-20) / 1 mL in 1 VIAL (55513-126-01) 10 vial2025-04-14NoNoHistorical