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
9bbe9a5b-ad1d-41a4-9699-ff6dc776bce1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
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 Code54868-5802
Application NumberBLA103234
Product Classification
M
Marketing Category
C73585
G
Generic Name
Erythropoietin
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 17, 2013
FDA Product Classification
INGREDIENTS (8)
ErythropoietinActive
Quantity: 40000 [iU] in 1 mL
Code: 64FS3BFH5W
Classification: ACTIB
albumin (human)Inactive
Quantity: 2.5 mg in 1 mL
Code: ZIF514RVZR
Classification: IACT
sodium citrateInactive
Quantity: 0.7 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
sodium chlorideInactive
Quantity: 5.8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
sodium phosphate, monobasic, monohydrateInactive
Quantity: 1.2 mg in 1 mL
Code: 593YOG76RN
Classification: IACT
citric acid monohydrateInactive
Quantity: 6.8 ug in 1 mL
Code: 2968PHW8QP
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium phosphate, dibasic, anhydrousInactive
Quantity: 1.8 mg in 1 mL
Code: 22ADO53M6F
Classification: IACT
Erythropoietin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-2523
Application NumberBLA103234
Product Classification
M
Marketing Category
C73585
G
Generic Name
Erythropoietin
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 17, 2013
FDA Product Classification
INGREDIENTS (6)
albumin (human)Inactive
Quantity: 2.5 mg in 1 mL
Code: ZIF514RVZR
Classification: IACT
ErythropoietinActive
Quantity: 10000 [iU] in 1 mL
Code: 64FS3BFH5W
Classification: ACTIB
sodium citrateInactive
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
Erythropoietin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5673
Application NumberBLA103234
Product Classification
M
Marketing Category
C73585
G
Generic Name
Erythropoietin
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 17, 2013
FDA Product Classification
INGREDIENTS (7)
ErythropoietinActive
Quantity: 20000 [iU] in 1 mL
Code: 64FS3BFH5W
Classification: ACTIB
albumin (human)Inactive
Quantity: 2.5 mg in 1 mL
Code: ZIF514RVZR
Classification: IACT
sodium chlorideInactive
Quantity: 5.8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
sodium citrateInactive
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
benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT