FDA.reportPublic FDA data

RETACRIT

Product NDC
59353-220
11-digit product format
593530220
Labeler code
59353
Product ID
59353-220_5626304b-344f-4155-9afa-d7cfe733d819
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
epoetin alfa-epbx
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Vifor (International) Inc.
Application
BLA125545
Marketing category
BLA
Marketing start
2020-09-11
Substance
EPOETIN
Active strength
10000 [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
RETACRITEPOETIN ALFA-EPBXVifor (International) Inc.e6e4dd0c-25ca-40b2-ba6b-6138a68621fe2025-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125545
ndc (product): 59353-220
RETACRITEPOETIN ALFA-EPBXPfizer Laboratories Div Pfizer Inc3af26b0d-8ad0-44e1-a538-8bdb5ab393742025-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125545

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPOETIN10000 [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
2047591Internal RxNorm lookup
2047596Internal RxNorm lookup
2047600Internal RxNorm lookup
2047602Internal RxNorm lookup
2047606Internal RxNorm lookup
2047608Internal RxNorm lookup
2047612Internal RxNorm lookup
2047614Internal RxNorm lookup
2463731Internal RxNorm lookup
2463733Internal RxNorm lookup
2463735Internal RxNorm lookup
2463737Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e6e4dd0c-25ca-40b2-ba6b-6138a68621feAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59353-220-01RETACRIT2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION214
59353-220-10RETACRIT10 in 1 CARTONINJECTION, SOLUTION1014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59353-220RETACRIT (EPOETIN ALFA-EPBX) INJECTION, SOLUTION [VIFOR (INTERNATIONAL) INC.]13Current NDC, Legacy NDC, 2 package rows20240627_e6e4dd0c-25ca-40b2-ba6b-6138a68621fe.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125545Retacritepoetin alfa-epbx351(k) BiosimilarRx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047591epoetin alfa-epbx 10,000 UNT in 1 ML InjectionPSNe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463731epoetin alfa-epbx 10,000 UNT/ML Injectable SolutionPSNe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463735epoetin alfa-epbx 20,000 UNT/ML Injectable SolutionPSNe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2047600epoetin alfa-epbx 2000 UNT in 1 ML InjectionPSNe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2047606epoetin alfa-epbx 3000 UNT in 1 ML InjectionPSNe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2047612epoetin alfa-epbx 4000 UNT in 1 ML InjectionPSNe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2047596Retacrit 10,000 UNT in 1 ML InjectionPSNe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463733Retacrit 10,000 UNT/ML Injectable SolutionPSNe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463737Retacrit 20,000 UNT/ML Injectable SolutionPSNe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2047602Retacrit 2000 UNT in 1 ML InjectionPSNe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2047608Retacrit 3000 UNT in 1 ML InjectionPSNe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2047614Retacrit 4000 UNT in 1 ML InjectionPSNe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20475961 ML epoetin alfa-epbx 10000 UNT/ML Injection [Retacrit]SBDe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476021 ML epoetin alfa-epbx 2000 UNT/ML Injection [Retacrit]SBDe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476081 ML epoetin alfa-epbx 3000 UNT/ML Injection [Retacrit]SBDe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476141 ML epoetin alfa-epbx 4000 UNT/ML Injection [Retacrit]SBDe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463733epoetin alfa-epbx 10000 UNT/ML Injectable Solution [Retacrit]SBDe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463737epoetin alfa-epbx 20000 UNT/ML Injectable Solution [Retacrit]SBDe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20475911 ML epoetin alfa-epbx 10000 UNT/ML InjectionSCDe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476001 ML epoetin alfa-epbx 2000 UNT/ML InjectionSCDe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476061 ML epoetin alfa-epbx 3000 UNT/ML InjectionSCDe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476121 ML epoetin alfa-epbx 4000 UNT/ML InjectionSCDe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463731epoetin alfa-epbx 10000 UNT/ML Injectable SolutionSCDe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463735epoetin alfa-epbx 20000 UNT/ML Injectable SolutionSCDe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20475911 ML EPO-epbx 10000 UNT/ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20475961 ML EPO-epbx 10000 UNT/ML Injection [Retacrit]SYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476001 ML EPO-epbx 2000 UNT/ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476021 ML EPO-epbx 2000 UNT/ML Injection [Retacrit]SYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476061 ML EPO-epbx 3000 UNT/ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476081 ML EPO-epbx 3000 UNT/ML Injection [Retacrit]SYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476121 ML EPO-epbx 4000 UNT/ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476141 ML EPO-epbx 4000 UNT/ML Injection [Retacrit]SYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20475911 ML ERYTHROPOIETIN-epbx 10000 UNT/ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20475961 ML ERYTHROPOIETIN-epbx 10000 UNT/ML Injection [Retacrit]SYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476001 ML ERYTHROPOIETIN-epbx 2000 UNT/ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476021 ML ERYTHROPOIETIN-epbx 2000 UNT/ML Injection [Retacrit]SYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476061 ML ERYTHROPOIETIN-epbx 3000 UNT/ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476081 ML ERYTHROPOIETIN-epbx 3000 UNT/ML Injection [Retacrit]SYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476121 ML ERYTHROPOIETIN-epbx 4000 UNT/ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476141 ML ERYTHROPOIETIN-epbx 4000 UNT/ML Injection [Retacrit]SYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20475961 ML Retacrit 10000 UNT/ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476021 ML Retacrit 2000 UNT/ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476081 ML Retacrit 3000 UNT/ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
20476141 ML Retacrit 4000 UNT/ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463731EPO-epbx 10000 UNT/ML Injectable SolutionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463733EPO-epbx 10000 UNT/ML Injectable Solution [Retacrit]SYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463735EPO-epbx 20000 UNT/ML Injectable SolutionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463737EPO-epbx 20000 UNT/ML Injectable Solution [Retacrit]SYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2047591epoetin alfa-epbx 10,000 UNT per 1 ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463731epoetin alfa-epbx 20,000 UNT per 2 ML Injectable SolutionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2047600epoetin alfa-epbx 2000 UNT per 1 ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2047606epoetin alfa-epbx 3000 UNT per 1 ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2047612epoetin alfa-epbx 4000 UNT per 1 ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463731ERYTHROPOIETIN-epbx 10000 UNT/ML Injectable SolutionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463733ERYTHROPOIETIN-epbx 10000 UNT/ML Injectable Solution [Retacrit]SYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463735ERYTHROPOIETIN-epbx 20000 UNT/ML Injectable SolutionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463737ERYTHROPOIETIN-epbx 20000 UNT/ML Injectable Solution [Retacrit]SYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463733Retacrit (epoetin alfa-epbx 20,000 UNT per 2 ML) Injectable SolutionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2047596Retacrit 10,000 UNT per 1 ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463733Retacrit 10000 UNT/ML Injectable SolutionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2047602Retacrit 2000 UNT per 1 ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2463737Retacrit 20000 UNT/ML Injectable SolutionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2047608Retacrit 3000 UNT per 1 ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14
2047614Retacrit 4000 UNT per 1 ML InjectionSYe6e4dd0c-25ca-40b2-ba6b-6138a68621fe14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59353-220-01593530220012 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
59353-220-105935302201010 VIAL, MULTI-DOSE in 1 CARTON (59353-220-10) / 2 mL in 1 VIAL, MULTI-DOSE (59353-220-01) 2020-11-090000-00-00NoNoCurrent