retacrit

Generic: epoetin alfa-epbx

Labeler: vifor (international) inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name retacrit
Generic Name epoetin alfa-epbx
Labeler vifor (international) inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

epoetin 10000 [iU]/mL

Manufacturer
Vifor (International) Inc.

Identifiers & Regulatory

Product NDC 59353-220
Product ID 59353-220_5626304b-344f-4155-9afa-d7cfe733d819
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125545
Listing Expiration 2026-12-31
Marketing Start 2020-09-11

Pharmacologic Class

Classes
erythropoiesis-stimulating agent [epc] erythropoietin [cs] increased erythroid cell production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59353220
Hyphenated Format 59353-220

Supplemental Identifiers

RxCUI
2047591 2047596 2047600 2047602 2047606 2047608 2047612 2047614 2463731 2463733 2463735 2463737
UNII
64FS3BFH5W

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name retacrit (source: ndc)
Generic Name epoetin alfa-epbx (source: ndc)
Application Number BLA125545 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10000 [iU]/mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 CARTON (59353-220-10) / 2 mL in 1 VIAL, MULTI-DOSE (59353-220-01)
source: ndc

Packages (1)

59353-220-10 10 VIAL, MULTI-DOSE in 1 CARTON (59353-220-10) / 2 mL in 1 VIAL, MULTI-DOSE (59353-220-01)

Ingredients (1)

epoetin (10000 [iU]/mL)

Linked Drug Pages (1)

RETACRIT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "5626304b-344f-4155-9afa-d7cfe733d819", "openfda": {"unii": ["64FS3BFH5W"], "rxcui": ["2047591", "2047596", "2047600", "2047602", "2047606", "2047608", "2047612", "2047614", "2463731", "2463733", "2463735", "2463737"], "spl_set_id": ["e6e4dd0c-25ca-40b2-ba6b-6138a68621fe"], "manufacturer_name": ["Vifor (International) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (59353-220-10)  / 2 mL in 1 VIAL, MULTI-DOSE (59353-220-01)", "package_ndc": "59353-220-10", "marketing_start_date": "20201109"}], "brand_name": "RETACRIT", "product_id": "59353-220_5626304b-344f-4155-9afa-d7cfe733d819", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Erythropoiesis-stimulating Agent [EPC]", "Erythropoietin [CS]", "Increased Erythroid Cell Production [PE]"], "product_ndc": "59353-220", "generic_name": "epoetin alfa-epbx", "labeler_name": "Vifor (International) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RETACRIT", "active_ingredients": [{"name": "EPOETIN", "strength": "10000 [iU]/mL"}], "application_number": "BLA125545", "marketing_category": "BLA", "marketing_start_date": "20200911", "listing_expiration_date": "20261231"}