PROCRIT
These highlights do not include all the information needed to use PROCRIT safely and effectively. See full prescribing information for PROCRIT. PROCRIT (epoetin alfa) injection, for intravenous or subcutaneous use Initial U.S. Approval: 1989
Approved
Approval ID
0c721ba4-ae19-417f-aae1-221ed1a0866a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2023
Manufacturers
FDA
Janssen Products, LP
DUNS: 804684207
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Erythropoietin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59676-312
Application NumberBLA103234
Product Classification
M
Marketing Category
C73585
G
Generic Name
Erythropoietin
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (7)
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.11 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
ALBUMIN HUMANInactive
Quantity: 2.5 mg in 1 mL
Code: ZIF514RVZR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
ERYTHROPOIETINActive
Quantity: 10000 [iU] in 1 mL
Code: 64FS3BFH5W
Classification: ACTIB
SODIUM CITRATE, UNSPECIFIED FORMInactive
Quantity: 1.3 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.2 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
Erythropoietin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59676-320
Application NumberBLA103234
Product Classification
M
Marketing Category
C73585
G
Generic Name
Erythropoietin
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (7)
SODIUM CITRATE, UNSPECIFIED FORMInactive
Quantity: 5.8 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALBUMIN HUMANInactive
Quantity: 2.5 mg in 1 mL
Code: ZIF514RVZR
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 5.8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.06 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
ERYTHROPOIETINActive
Quantity: 20000 [iU] in 1 mL
Code: 64FS3BFH5W
Classification: ACTIB
Erythropoietin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59676-310
Application NumberBLA103234
Product Classification
M
Marketing Category
C73585
G
Generic Name
Erythropoietin
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (6)
ALBUMIN HUMANInactive
Quantity: 2.5 mg in 1 mL
Code: ZIF514RVZR
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Quantity: 5.8 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.06 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 5.8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ERYTHROPOIETINActive
Quantity: 10000 [iU] in 1 mL
Code: 64FS3BFH5W
Classification: ACTIB
Erythropoietin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59676-302
Application NumberBLA103234
Product Classification
M
Marketing Category
C73585
G
Generic Name
Erythropoietin
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (6)
ALBUMIN HUMANInactive
Quantity: 2.5 mg in 1 mL
Code: ZIF514RVZR
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Quantity: 5.8 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.06 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 5.8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ERYTHROPOIETINActive
Quantity: 2000 [iU] in 1 mL
Code: 64FS3BFH5W
Classification: ACTIB
Erythropoietin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59676-304
Application NumberBLA103234
Product Classification
M
Marketing Category
C73585
G
Generic Name
Erythropoietin
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Quantity: 5.8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Quantity: 5.8 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
ALBUMIN HUMANInactive
Quantity: 2.5 mg in 1 mL
Code: ZIF514RVZR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.06 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ERYTHROPOIETINActive
Quantity: 4000 [iU] in 1 mL
Code: 64FS3BFH5W
Classification: ACTIB
Erythropoietin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59676-340
Application NumberBLA103234
Product Classification
M
Marketing Category
C73585
G
Generic Name
Erythropoietin
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (8)
ALBUMIN HUMANInactive
Quantity: 2.5 mg in 1 mL
Code: ZIF514RVZR
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 1.2 mg in 1 mL
Code: 593YOG76RN
Classification: IACT
ERYTHROPOIETINActive
Quantity: 40000 [iU] in 1 mL
Code: 64FS3BFH5W
Classification: ACTIB
SODIUM CITRATE, UNSPECIFIED FORMInactive
Quantity: 0.7 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 5.8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 6.8 ug in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 1.8 mg in 1 mL
Code: 22ADO53M6F
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Erythropoietin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59676-303
Application NumberBLA103234
Product Classification
M
Marketing Category
C73585
G
Generic Name
Erythropoietin
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (6)
ALBUMIN HUMANInactive
Quantity: 2.5 mg in 1 mL
Code: ZIF514RVZR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.06 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Quantity: 5.8 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 5.8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ERYTHROPOIETINActive
Quantity: 3000 [iU] in 1 mL
Code: 64FS3BFH5W
Classification: ACTIB