FDA.reportPublic FDA data

PROCRIT

Product NDC
59676-310
11-digit product format
596760310
Labeler code
59676
Product ID
59676-310_325d5d88-413d-28a2-e063-6394a90a3948
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythropoietin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Janssen Products, LP
Application
BLA103234
Marketing category
BLA
Marketing start
1989-06-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
PROCRIT
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 · 14 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205913Internal RxNorm lookup
205918Internal RxNorm lookup
205922Internal RxNorm lookup
205924Internal RxNorm lookup
212219Internal RxNorm lookup
213475Internal RxNorm lookup
239998Internal RxNorm lookup
239999Internal RxNorm lookup
240000Internal RxNorm lookup
240377Internal RxNorm lookup
241999Internal RxNorm lookup
242706Internal RxNorm lookup
1721684Internal RxNorm lookup
1721690Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0c721ba4-ae19-417f-aae1-221ed1a0866aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
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
59676-310-00PROCRIT1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION131
59676-310-01PROCRIT6 in 1 CARTONINJECTION, SOLUTION631
59676-310-02PROCRIT25 in 1 CARTONINJECTION, SOLUTION2531

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59676-310-00ML - Milliliter59676-3107d7598bc-ad9c-4172-b22a-1257661e496412012-07-24
59676-310-01ML - Milliliter59676-31025e06fd5-fd52-4e8e-932b-80ed8a6d697012012-07-24
59676-310-02ML - Milliliter59676-3104b4f460d-3718-425b-a661-7deb1d17d82612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ErythropoietinACTIVE INGREDIENT64FS3BFH5WPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
ErythropoietinACTIVE MOIETY64FS3BFH5WPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
albumin (human)INACTIVE INGREDIENTZIF514RVZRPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
sodium chlorideINACTIVE INGREDIENT451W47IQ8XPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
sodium phosphate, dibasic, anhydrousINACTIVE INGREDIENT22ADO53M6FPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
sodium phosphate, monobasic, monohydrateINACTIVE INGREDIENT593YOG76RNPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
waterINACTIVE INGREDIENT059QF0KO0RPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
ErythropoietinACTIVE INGREDIENT64FS3BFH5WPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
ErythropoietinACTIVE MOIETY64FS3BFH5WPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
albumin (human)INACTIVE INGREDIENTZIF514RVZRPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
sodium chlorideINACTIVE INGREDIENT451W47IQ8XPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
sodium phosphate, dibasic, anhydrousINACTIVE INGREDIENT22ADO53M6FPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
sodium phosphate, monobasic, monohydrateINACTIVE INGREDIENT593YOG76RNPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59676-310PROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]31Current NDC, Legacy NDC, 3 package rows20250410_0c721ba4-ae19-417f-aae1-221ed1a0866a.zip

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 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
PROCRITERYTHROPOIETINJanssen Products, LP0c721ba4-ae19-417f-aae1-221ed1a0866a2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103234
ndc (product): 59676-310

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 InjectionPSN0c721ba4-ae19-417f-aae1-221ed1a0866a31
240000epoetin alfa 10,000 UNT/ML Injectable SolutionPSN0c721ba4-ae19-417f-aae1-221ed1a0866a31
241999epoetin alfa 20,000 UNT/ML Injectable SolutionPSN0c721ba4-ae19-417f-aae1-221ed1a0866a31
239998epoetin alfa 2000 UNT in 1 ML InjectionPSN0c721ba4-ae19-417f-aae1-221ed1a0866a31
240377epoetin alfa 3000 UNT in 1 ML InjectionPSN0c721ba4-ae19-417f-aae1-221ed1a0866a31
242706epoetin alfa 40,000 UNT in 1 ML InjectionPSN0c721ba4-ae19-417f-aae1-221ed1a0866a31
239999epoetin alfa 4000 UNT in 1 ML InjectionPSN0c721ba4-ae19-417f-aae1-221ed1a0866a31
1721690PROCRIT 10,000 UNT in 1 ML InjectionPSN0c721ba4-ae19-417f-aae1-221ed1a0866a31
205913PROCRIT 10,000 UNT/ML Injectable SolutionPSN0c721ba4-ae19-417f-aae1-221ed1a0866a31
212219PROCRIT 20,000 UNT/ML Injectable SolutionPSN0c721ba4-ae19-417f-aae1-221ed1a0866a31
205918PROCRIT 2000 UNT in 1 ML InjectionPSN0c721ba4-ae19-417f-aae1-221ed1a0866a31
205922PROCRIT 3000 UNT in 1 ML InjectionPSN0c721ba4-ae19-417f-aae1-221ed1a0866a31
213475PROCRIT 40,000 UNT in 1 ML InjectionPSN0c721ba4-ae19-417f-aae1-221ed1a0866a31
205924PROCRIT 4000 UNT in 1 ML InjectionPSN0c721ba4-ae19-417f-aae1-221ed1a0866a31
17216901 ML epoetin alfa 10000 UNT/ML Injection [Procrit]SBD0c721ba4-ae19-417f-aae1-221ed1a0866a31
2059181 ML epoetin alfa 2000 UNT/ML Injection [Procrit]SBD0c721ba4-ae19-417f-aae1-221ed1a0866a31
2059221 ML epoetin alfa 3000 UNT/ML Injection [Procrit]SBD0c721ba4-ae19-417f-aae1-221ed1a0866a31
2059241 ML epoetin alfa 4000 UNT/ML Injection [Procrit]SBD0c721ba4-ae19-417f-aae1-221ed1a0866a31
2134751 ML epoetin alfa 40000 UNT/ML Injection [Procrit]SBD0c721ba4-ae19-417f-aae1-221ed1a0866a31
205913epoetin alfa 10000 UNT/ML Injectable Solution [Procrit]SBD0c721ba4-ae19-417f-aae1-221ed1a0866a31
212219epoetin alfa 20000 UNT/ML Injectable Solution [Procrit]SBD0c721ba4-ae19-417f-aae1-221ed1a0866a31
17216841 ML epoetin alfa 10000 UNT/ML InjectionSCD0c721ba4-ae19-417f-aae1-221ed1a0866a31
2399981 ML epoetin alfa 2000 UNT/ML InjectionSCD0c721ba4-ae19-417f-aae1-221ed1a0866a31
2403771 ML epoetin alfa 3000 UNT/ML InjectionSCD0c721ba4-ae19-417f-aae1-221ed1a0866a31
2399991 ML epoetin alfa 4000 UNT/ML InjectionSCD0c721ba4-ae19-417f-aae1-221ed1a0866a31
2427061 ML epoetin alfa 40000 UNT/ML InjectionSCD0c721ba4-ae19-417f-aae1-221ed1a0866a31
240000epoetin alfa 10000 UNT/ML Injectable SolutionSCD0c721ba4-ae19-417f-aae1-221ed1a0866a31
241999epoetin alfa 20000 UNT/ML Injectable SolutionSCD0c721ba4-ae19-417f-aae1-221ed1a0866a31
17216841 ML EPO 10000 UNT/ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
17216901 ML EPO 10000 UNT/ML Injection [Procrit]SY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2399981 ML EPO 2000 UNT/ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2059181 ML EPO 2000 UNT/ML Injection [Procrit]SY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2403771 ML EPO 3000 UNT/ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2059221 ML EPO 3000 UNT/ML Injection [Procrit]SY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2399991 ML EPO 4000 UNT/ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2059241 ML EPO 4000 UNT/ML Injection [Procrit]SY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2427061 ML EPO 40000 UNT/ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2134751 ML EPO 40000 UNT/ML Injection [Procrit]SY0c721ba4-ae19-417f-aae1-221ed1a0866a31
17216841 ML ERYTHROPOIETIN 10000 UNT/ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
17216901 ML ERYTHROPOIETIN 10000 UNT/ML Injection [Procrit]SY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2399981 ML ERYTHROPOIETIN 2000 UNT/ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2059181 ML ERYTHROPOIETIN 2000 UNT/ML Injection [Procrit]SY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2403771 ML ERYTHROPOIETIN 3000 UNT/ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2059221 ML ERYTHROPOIETIN 3000 UNT/ML Injection [Procrit]SY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2399991 ML ERYTHROPOIETIN 4000 UNT/ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2059241 ML ERYTHROPOIETIN 4000 UNT/ML Injection [Procrit]SY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2427061 ML ERYTHROPOIETIN 40000 UNT/ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2134751 ML ERYTHROPOIETIN 40000 UNT/ML Injection [Procrit]SY0c721ba4-ae19-417f-aae1-221ed1a0866a31
17216901 ML Procrit 10000 UNT/ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2059181 ML Procrit 2000 UNT/ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2059221 ML Procrit 3000 UNT/ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2059241 ML Procrit 4000 UNT/ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
2134751 ML Procrit 40000 UNT/ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
240000EPO 10000 UNT/ML Injectable SolutionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
205913EPO 10000 UNT/ML Injectable Solution [Procrit]SY0c721ba4-ae19-417f-aae1-221ed1a0866a31
241999EPO 20000 UNT/ML Injectable SolutionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
212219EPO 20000 UNT/ML Injectable Solution [Procrit]SY0c721ba4-ae19-417f-aae1-221ed1a0866a31
1721684epoetin alfa 10,000 UNT per 1 ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
239998epoetin alfa 2000 UNT per 1 ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
240377epoetin alfa 3000 UNT per 1 ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
242706epoetin alfa 40,000 UNT per 1 ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
239999epoetin alfa 4000 UNT per 1 ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
240000ERYTHROPOIETIN 10000 UNT/ML Injectable SolutionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
205913ERYTHROPOIETIN 10000 UNT/ML Injectable Solution [Procrit]SY0c721ba4-ae19-417f-aae1-221ed1a0866a31
241999ERYTHROPOIETIN 20000 UNT/ML Injectable SolutionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
212219ERYTHROPOIETIN 20000 UNT/ML Injectable Solution [Procrit]SY0c721ba4-ae19-417f-aae1-221ed1a0866a31
1721690Procrit 10,000 UNT per 1 ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
205913Procrit 10,000 UNT/ML Injectable SolutionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
205918Procrit 2000 UNT per 1 ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
212219Procrit 20000 UNT/ML Injectable SolutionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
205922Procrit 3000 UNT per 1 ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
213475Procrit 40,000 UNT per 1 ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
205924Procrit 4000 UNT per 1 ML InjectionSY0c721ba4-ae19-417f-aae1-221ed1a0866a31
1721684epoetin alfa 10,000 UNT in 1 ML InjectionPSN9bbe9a5b-ad1d-41a4-9699-ff6dc776bce12
241999epoetin alfa 20,000 UNT/ML Injectable SolutionPSN9bbe9a5b-ad1d-41a4-9699-ff6dc776bce12
242706epoetin alfa 40,000 UNT in 1 ML InjectionPSN9bbe9a5b-ad1d-41a4-9699-ff6dc776bce12
1721690PROCRIT 10,000 UNT in 1 ML InjectionPSN9bbe9a5b-ad1d-41a4-9699-ff6dc776bce12
212219PROCRIT 20,000 UNT/ML Injectable SolutionPSN9bbe9a5b-ad1d-41a4-9699-ff6dc776bce12
213475PROCRIT 40,000 UNT in 1 ML InjectionPSN9bbe9a5b-ad1d-41a4-9699-ff6dc776bce12
17216901 ML epoetin alfa 10000 UNT/ML Injection [Procrit]SBD9bbe9a5b-ad1d-41a4-9699-ff6dc776bce12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59676-310-00596760310001 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
59676-310-01596760310016 VIAL, SINGLE-DOSE in 1 CARTON (59676-310-01) / 1 mL in 1 VIAL, SINGLE-DOSE (59676-310-00) 1989-06-010000-00-00NoNoCurrent
59676-310-025967603100225 VIAL, SINGLE-DOSE in 1 CARTON (59676-310-02) / 1 mL in 1 VIAL, SINGLE-DOSE (59676-310-00) 1989-06-010000-00-00NoNoCurrent