pemgarda

UNIISPL

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

Identification

ManufacturerInvivyd, Inc

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8196003103
9 VIAL, SINGLE-DOSE in 1 CARTON (81960-031-03) / 4 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

557S3L3FAP

PEMIVIBART

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "557S3L3FAP",
    "rxcui": null,
    "inchikey": null,
    "display_name": "PEMIVIBART",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "0bdc20a9-791f-9a06-e063-6394a90a84cc": {
      "match": "brand_token",
      "title": "PEMGARDA (PEMIVIBART) INJECTION [INVIVYD, INC]",
      "spl_version": "10",
      "published_date": "2026-05-14"
    }
  },
  "productid": "81960-031_4b1b8d43-0bf4-849a-e063-6294a90abfb4",
  "productndc": "81960-031",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PEMIVIBART",
  "proprietary_name": "pemgarda",
  "active_ingred_unit": "mg/mL",
  "application_number": "EUA000122",
  "marketing_category": "EMERGENCY USE AUTHORIZATION",
  "nonproprietary_name": "pemivibart",
  "start_marketing_date": "20240322",
  "active_numerator_strength": "125"
}

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