mNEXSPIKE

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
8077740060
10 SYRINGE, PLASTIC in 1 CARTON (80777-400-60) / .2 mL in 1 SYRINGE, PLASTIC (80777-400-17)
ndc11
8077740061
2 SYRINGE, PLASTIC in 1 CARTON (80777-400-61) / .2 mL in 1 SYRINGE, PLASTIC (80777-400-17)
ndc11
8077740062
1 SYRINGE, PLASTIC in 1 CARTON (80777-400-62) / .2 mL in 1 SYRINGE, PLASTIC (80777-400-17)

Annotations

UNII (FDA Substance ID)

KFZ2Z65LB6

CX-052075

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "KFZ2Z65LB6",
    "rxcui": null,
    "inchikey": null,
    "display_name": "CX-052075",
    "substance_type": "nucleicAcid",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "97c27eb6-1d2e-4953-afac-882ada70c6f8": {
      "match": "brand_token",
      "title": "MNEXSPIKE (COVID-19 VACCINE, MRNA) INJECTION, SUSPENSION [MODERNA US, INC.]",
      "spl_version": "1",
      "published_date": "2025-09-01"
    }
  },
  "productid": "80777-400_97c27eb6-1d2e-4953-afac-882ada70c6f8",
  "productndc": "80777-400",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": "CX-052075",
  "proprietary_name": "mNEXSPIKE",
  "active_ingred_unit": "ug/.2mL",
  "application_number": "BLA125835",
  "marketing_category": "BLA",
  "nonproprietary_name": "COVID-19 Vaccine, mRNA",
  "start_marketing_date": "20250827",
  "active_numerator_strength": "10"
}

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