FDA.reportPublic FDA data

PROCRIT

Product NDC
59676-320
11-digit product format
596760320
Labeler code
59676
Product ID
59676-320_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
20000 [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
EPOETIN20000 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64FS3BFH5W
Rxcui205913, 205918, 205922, 205924, 212219, 213475, 239998, 239999, 240000, 240377, 241999, 242706, 1721684, 1721690

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
59676-320-00PROCRIT1 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION131
59676-320-04PROCRIT4 in 1 CARTONINJECTION, SOLUTION431

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59676-320-00ML - Milliliter59676-3201c772b64-8ff3-47f5-8a0a-4694fe62c14112013-06-04
59676-320-04ML - Milliliter59676-320dfea93c9-82ed-4d5a-a066-edce7b4b953912012-07-24

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
59676-320PROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]31Current NDC, Legacy NDC, 2 package rows20250410_0c721ba4-ae19-417f-aae1-221ed1a0866a.zip

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
59676-320-00596760320001 mL in 1 VIAL, MULTI-DOSE1 mlHistorical
59676-320-04596760320044 VIAL, MULTI-DOSE in 1 CARTON (59676-320-04) / 1 mL in 1 VIAL, MULTI-DOSE (59676-320-00) 1989-06-010000-00-00NoNoCurrent