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United States · US · US:83257-003_ef07d382-d369-dfad-1491-3a4cc3b57d01

OGIVRI

UNIISPLATC L01FD01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBiocon Biologics Inc.
CountryUS (United States)
ATC codeL01FD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
P188ANX8CK
TRASTUZUMAB
RxCUI 224905
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "P188ANX8CK",
    "rxcui": "224905",
    "inchikey": null,
    "display_name": "TRASTUZUMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "b6465b44-a6dd-f99c-d009-6851cf05169c": {
      "match": "brand_token",
      "title": "OGIVRI (TRASTUZUMAB-DKST) KIT OGIVRI (TRASTUZUMAB-DKST) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BIOCON BIOLOGICS INC.]",
      "spl_version": "14",
      "published_date": "2024-12-12"
    }
  },
  "productid": "83257-003_ef07d382-d369-dfad-1491-3a4cc3b57d01",
  "productndc": "83257-003",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRASTUZUMAB",
  "proprietary_name": "OGIVRI",
  "active_ingred_unit": "mg/20mL",
  "application_number": "BLA761074",
  "marketing_category": "BLA",
  "nonproprietary_name": "trastuzumab-dkst",
  "start_marketing_date": "20231001",
  "active_numerator_strength": "420"
}

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