NDC 59353-004

RETACRIT

Epoetin Alfa-epbx

RETACRIT is a Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Vifor (international) Inc.. The primary component is Erythropoietin.

Product ID59353-004_3adf0922-a716-4bad-88b6-983a2e259a44
NDC59353-004
Product TypeHuman Prescription Drug
Proprietary NameRETACRIT
Generic NameEpoetin Alfa-epbx
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2018-06-18
Marketing CategoryBLA / BLA
Application NumberBLA125545
Labeler NameVifor (International) Inc.
Substance NameERYTHROPOIETIN
Active Ingredient Strength4000 [iU]/mL
Pharm ClassesErythropoiesis-stimulating Agent [EPC],Erythropoietin [CS],Increased Erythroid Cell Production [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 59353-004-10

10 VIAL, SINGLE-DOSE in 1 CARTON (59353-004-10) > 1 mL in 1 VIAL, SINGLE-DOSE (59353-004-01)
Marketing Start Date2018-06-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59353-004-10 [59353000410]

RETACRIT INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125545
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-06-18

NDC 59353-004-01 [59353000401]

RETACRIT INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125545
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-06-18

Drug Details

Active Ingredients

IngredientStrength
ERYTHROPOIETIN4000 [iU]/mL

OpenFDA Data

SPL SET ID:e6e4dd0c-25ca-40b2-ba6b-6138a68621fe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2047606
  • 2047602
  • 2047600
  • 2047608
  • 2047591
  • 2047596
  • 2047612
  • 2047614
  • Pharmacological Class

    • Erythropoiesis-stimulating Agent [EPC]
    • Erythropoietin [CS]
    • Increased Erythroid Cell Production [PE]

    NDC Crossover Matching brand name "RETACRIT" or generic name "Epoetin Alfa-epbx"

    NDCBrand NameGeneric Name
    0069-1305RETACRITepoetin alfa-epbx
    0069-1306RETACRITepoetin alfa-epbx
    0069-1307RETACRITepoetin alfa-epbx
    0069-1308RETACRITepoetin alfa-epbx
    0069-1309RETACRITepoetin alfa-epbx
    0069-1311RETACRITepoetin alfa-epbx
    0069-1318RETACRITepoetin alfa-epbx
    59353-004RETACRITRETACRIT
    59353-002RETACRITRETACRIT
    59353-003RETACRITRETACRIT
    59353-010RETACRITRETACRIT
    59353-120RETACRITRETACRIT
    59353-220RETACRITRETACRIT

    Trademark Results [RETACRIT]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RETACRIT
    RETACRIT
    87340145 5770173 Live/Registered
    Hospira, Inc.
    2017-02-17
    RETACRIT
    RETACRIT
    85028565 3925022 Dead/Cancelled
    Hospira, Inc.
    2010-05-03
    RETACRIT
    RETACRIT
    77117569 not registered Dead/Abandoned
    Hospira, Inc.
    2007-02-27

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