Manufacturing Establishments3
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Patheon Manufacturing Services LLC
Janssen Products, LP
079415560
Amgen, Inc.
Janssen Products, LP
039976196
Amgen Manufacturing Ltd
Janssen Products, LP
785800020
Products7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PROCRIT
Product Details
NDC Product Code
59676-312Application Number
BLA103234Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
November 1, 2023CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.11 mg in 1 mL
ALBUMIN HUMANInactive
Code: ZIF514RVZRClass: IACTQuantity: 2.5 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
ErythropoietinActive
Code: 64FS3BFH5WClass: ACTIBQuantity: 10000 [iU] in 1 mL
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 1.3 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8.2 mg in 1 mL
PROCRIT
Product Details
NDC Product Code
59676-320Application Number
BLA103234Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
November 1, 2023SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 5.8 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
ALBUMIN HUMANInactive
Code: ZIF514RVZRClass: IACTQuantity: 2.5 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 5.8 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.06 mg in 1 mL
ErythropoietinActive
Code: 64FS3BFH5WClass: ACTIBQuantity: 20000 [iU] in 1 mL
PROCRIT
Product Details
NDC Product Code
59676-310Application Number
BLA103234Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
November 1, 2023ALBUMIN HUMANInactive
Code: ZIF514RVZRClass: IACTQuantity: 2.5 mg in 1 mL
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 5.8 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.06 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 5.8 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ErythropoietinActive
Code: 64FS3BFH5WClass: ACTIBQuantity: 10000 [iU] in 1 mL
PROCRIT
Product Details
NDC Product Code
59676-302Application Number
BLA103234Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
November 1, 2023ALBUMIN HUMANInactive
Code: ZIF514RVZRClass: IACTQuantity: 2.5 mg in 1 mL
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 5.8 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.06 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 5.8 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ErythropoietinActive
Code: 64FS3BFH5WClass: ACTIBQuantity: 2000 [iU] in 1 mL
PROCRIT
Product Details
NDC Product Code
59676-304Application Number
BLA103234Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
November 1, 2023SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 5.8 mg in 1 mL
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 5.8 mg in 1 mL
ALBUMIN HUMANInactive
Code: ZIF514RVZRClass: IACTQuantity: 2.5 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.06 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ErythropoietinActive
Code: 64FS3BFH5WClass: ACTIBQuantity: 4000 [iU] in 1 mL
PROCRIT
Product Details
NDC Product Code
59676-340Application Number
BLA103234Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
November 1, 2023ALBUMIN HUMANInactive
Code: ZIF514RVZRClass: IACTQuantity: 2.5 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RNClass: IACTQuantity: 1.2 mg in 1 mL
ErythropoietinActive
Code: 64FS3BFH5WClass: ACTIBQuantity: 40000 [iU] in 1 mL
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 0.7 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 5.8 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 6.8 ug in 1 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6FClass: IACTQuantity: 1.8 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
PROCRIT
Product Details
NDC Product Code
59676-303Application Number
BLA103234Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
November 1, 2023ALBUMIN HUMANInactive
Code: ZIF514RVZRClass: IACTQuantity: 2.5 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.06 mg in 1 mL
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 5.8 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 5.8 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ErythropoietinActive
Code: 64FS3BFH5WClass: ACTIBQuantity: 3000 [iU] in 1 mL