NDC 0069-1308

RETACRIT

Epoetin Alfa-epbx

RETACRIT is a Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Erythropoietin.

Product ID0069-1308_096e8e7a-2e35-400b-879c-480b935b5a8a
NDC0069-1308
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 NamePfizer Laboratories Div Pfizer Inc
Substance NameERYTHROPOIETIN
Active Ingredient Strength10000 [iU]/mL
Pharm ClassesErythropoiesis-stimulating Agent [EPC],Erythropoietin [CS],Increased Erythroid Cell Production [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0069-1308-10

10 VIAL, SINGLE-DOSE in 1 CARTON (0069-1308-10) > 1 mL in 1 VIAL, SINGLE-DOSE (0069-1308-01)
Marketing Start Date2018-06-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-1308-10 [00069130810]

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

NDC 0069-1308-01 [00069130801]

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

Drug Details

Active Ingredients

IngredientStrength
ERYTHROPOIETIN10000 [iU]/mL

OpenFDA Data

SPL SET ID:3af26b0d-8ad0-44e1-a538-8bdb5ab39374
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2047606
  • 2047602
  • 2047600
  • 2047608
  • 2047621
  • 2047591
  • 2047596
  • 2047612
  • 2047614
  • 2047623
  • 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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