Spikevax

UNIISPL

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

Identification

ManufacturerModerna US, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
8077711288
2 SYRINGE, PLASTIC in 1 CARTON (80777-112-88) / .5 mL in 1 SYRINGE, PLASTIC (80777-112-01)
ndc11
8077711293
10 SYRINGE, PLASTIC in 1 CARTON (80777-112-93) / .5 mL in 1 SYRINGE, PLASTIC (80777-112-01)
ndc11
8077711296
10 SYRINGE, PLASTIC in 1 CARTON (80777-112-96) / .5 mL in 1 SYRINGE, PLASTIC (80777-112-01)

Annotations

UNII (FDA Substance ID)

S5DYY8V79P

CX-051869

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "S5DYY8V79P",
    "rxcui": null,
    "inchikey": null,
    "display_name": "CX-051869",
    "substance_type": "nucleicAcid",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "f96b315c-fa57-4876-a7e5-a9b584d8e6e6": {
      "match": "brand_token",
      "title": "SPIKEVAX (COVID-19 VACCINE, MRNA) INJECTION, SUSPENSION [MODERNA US, INC.]",
      "spl_version": "10",
      "published_date": "2025-09-01"
    }
  },
  "productid": "80777-112_112d8af9-0172-4129-a89f-c76f20b366a7",
  "productndc": "80777-112",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": "CX-051869",
  "proprietary_name": "Spikevax",
  "active_ingred_unit": "ug/.5mL",
  "application_number": "BLA125752",
  "marketing_category": "BLA",
  "nonproprietary_name": "COVID-19 Vaccine, mRNA",
  "start_marketing_date": "20250827",
  "active_numerator_strength": "50"
}

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