OGIVRI

SPL

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

Identification

ManufacturerBiocon Biologics Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8325700412
1 KIT in 1 CARTON (83257-004-12) * 20 mL in 1 VIAL, MULTI-DOSE (83257-003-11) * 20 mL in 1 VIAL (83257-002-11)

Annotations

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "83257-004_ef07d382-d369-dfad-1491-3a4cc3b57d01",
  "productndc": "83257-004",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "OGIVRI",
  "active_ingred_unit": null,
  "application_number": "BLA761074",
  "marketing_category": "BLA",
  "nonproprietary_name": "trastuzumab-dkst",
  "start_marketing_date": "20231001",
  "active_numerator_strength": null
}

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