Mircera

UNIISPLATC B03XA03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerVifor (International) Inc.

CountryUS (United States)

ATC codeB03XA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5935340109
1 SYRINGE, GLASS in 1 CARTON (59353-401-09) / 1 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)

LR3UXN0193

METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA

RxCUI 729596

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "LR3UXN0193",
    "rxcui": "729596",
    "inchikey": null,
    "display_name": "METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "22c56f2a-f73c-60e7-e054-00144ff88e88": {
      "match": "brand_token",
      "title": "MIRCERA (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) INJECTION, SOLUTION [VIFOR (INTERNATIONAL) INC.]",
      "spl_version": "9",
      "published_date": "2024-06-17"
    }
  },
  "productid": "59353-401_24eb3030-78a2-44cc-b150-c09ec0f080af",
  "productndc": "59353-401",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA",
  "proprietary_name": "Mircera",
  "active_ingred_unit": "ug/.3mL",
  "application_number": "BLA125164",
  "marketing_category": "BLA",
  "nonproprietary_name": "Methoxy polyethylene glycol-epoetin beta",
  "start_marketing_date": "20141024",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code B03XA03.

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