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 · 2

ndc11
8077711380
10 SYRINGE, PLASTIC in 1 CARTON (80777-113-80) / .25 mL in 1 SYRINGE, PLASTIC (80777-113-09)
ndc11
8077711387
2 SYRINGE, PLASTIC in 1 CARTON (80777-113-87) / .25 mL in 1 SYRINGE, PLASTIC (80777-113-09)

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": "80777-113_112d8af9-0172-4129-a89f-c76f20b366a7",
  "productndc": "80777-113",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": "CX-051869",
  "proprietary_name": "Spikevax",
  "active_ingred_unit": "ug/.25mL",
  "application_number": "BLA125752",
  "marketing_category": "BLA",
  "nonproprietary_name": "COVID-19 Vaccine, mRNA",
  "start_marketing_date": "20250827",
  "active_numerator_strength": "25"
}

Access this data programmatically

Query Spikevax and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs