Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products3
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
54868-5802Application Number
BLA103234Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
January 17, 2013ErythropoietinActive
Code: 64FS3BFH5WClass: ACTIBQuantity: 40000 [iU] in 1 mL
albumin (human)Inactive
Code: ZIF514RVZRClass: IACTQuantity: 2.5 mg in 1 mL
sodium citrateInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 0.7 mg in 1 mL
sodium chlorideInactive
Code: 451W47IQ8XClass: IACTQuantity: 5.8 mg in 1 mL
sodium phosphate, monobasic, monohydrateInactive
Code: 593YOG76RNClass: IACTQuantity: 1.2 mg in 1 mL
citric acid monohydrateInactive
Code: 2968PHW8QPClass: IACTQuantity: 6.8 ug in 1 mL
waterInactive
Code: 059QF0KO0RClass: IACT
sodium phosphate, dibasic, anhydrousInactive
Code: 22ADO53M6FClass: IACTQuantity: 1.8 mg in 1 mL
PROCRIT
Product Details
NDC Product Code
54868-2523Application Number
BLA103234Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
January 17, 2013albumin (human)Inactive
Code: ZIF514RVZRClass: IACTQuantity: 2.5 mg in 1 mL
ErythropoietinActive
Code: 64FS3BFH5WClass: ACTIBQuantity: 10000 [iU] in 1 mL
sodium citrateInactive
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
PROCRIT
Product Details
NDC Product Code
54868-5673Application Number
BLA103234Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
January 17, 2013ErythropoietinActive
Code: 64FS3BFH5WClass: ACTIBQuantity: 20000 [iU] in 1 mL
albumin (human)Inactive
Code: ZIF514RVZRClass: IACTQuantity: 2.5 mg in 1 mL
sodium chlorideInactive
Code: 451W47IQ8XClass: IACTQuantity: 5.8 mg in 1 mL
sodium citrateInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 5.8 mg in 1 mL
citric acid monohydrateInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.06 mg in 1 mL
benzyl alcoholInactive
Code: LKG8494WBHClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT