FDA.reportPublic FDA data

RETACRIT

Product NDC
59353-004
11-digit product format
593530004
Labeler code
59353
Product ID
59353-004_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
2018-06-18
Substance
EPOETIN
Active strength
4000 [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
RETACRIT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPOETIN4000 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64FS3BFH5W
Rxcui2047591, 2047596, 2047600, 2047602, 2047606, 2047608, 2047612, 2047614, 2463731, 2463733, 2463735, 2463737

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
59353-004-01RETACRIT1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION114
59353-004-10RETACRIT10 in 1 CARTONINJECTION, SOLUTION1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59353-004-01ML - Milliliter59353-0040eb918ae-5b8e-4c1b-8d85-93ebe4db071712018-07-03
59353-004-10ML - Milliliter59353-0044aedfaa4-30a6-4fae-882d-ad49e2417c0b12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59353-004RETACRIT (EPOETIN ALFA-EPBX) INJECTION, SOLUTION [VIFOR (INTERNATIONAL) INC.]13Current NDC, Legacy NDC, 2 package rows20240627_e6e4dd0c-25ca-40b2-ba6b-6138a68621fe.zip

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
59353-004-01593530004011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
59353-004-105935300041010 VIAL, SINGLE-DOSE in 1 CARTON (59353-004-10) / 1 mL in 1 VIAL, SINGLE-DOSE (59353-004-01) 2018-06-180000-00-00NoNoCurrent