mRESVIA

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 · 6

ndc11
8077734561
10 SYRINGE in 1 CARTON (80777-345-61) / .5 mL in 1 SYRINGE (80777-345-01)
ndc11
8077734562
1 SYRINGE in 1 CARTON (80777-345-62) / .5 mL in 1 SYRINGE (80777-345-01)
ndc11
8077734563
2 SYRINGE in 1 CARTON (80777-345-63) / .5 mL in 1 SYRINGE (80777-345-01)
ndc11
8077734589
2 SYRINGE in 1 CARTON (80777-345-89) / .5 mL in 1 SYRINGE (80777-345-01)
ndc11
8077734590
1 SYRINGE in 1 CARTON (80777-345-90) / .5 mL in 1 SYRINGE (80777-345-01)
ndc11
8077734596
10 SYRINGE in 1 CARTON (80777-345-96) / .5 mL in 1 SYRINGE (80777-345-01)

Annotations

UNII (FDA Substance ID)

2ZKG2M978D

RNA-100-AR02

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "2ZKG2M978D",
    "rxcui": null,
    "inchikey": null,
    "display_name": "RNA-100-AR02",
    "substance_type": "nucleicAcid",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "e5c837e7-41e8-496a-9c85-6b0453b35948": {
      "match": "brand_token",
      "title": "MRESVIA (RESPIRATORY SYNCYTIAL VIRUS VACCINE) SUSPENSION [MODERNA US, INC.]",
      "spl_version": "5",
      "published_date": "2025-06-25"
    }
  },
  "productid": "80777-345_22c62288-16df-4cd5-8fff-f84668f54471",
  "productndc": "80777-345",
  "dosage_form": "SUSPENSION",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": "RNA-100-AR02",
  "proprietary_name": "mRESVIA",
  "active_ingred_unit": "ug/.5mL",
  "application_number": "BLA125796",
  "marketing_category": "BLA",
  "nonproprietary_name": "Respiratory Syncytial Virus Vaccine",
  "start_marketing_date": "20240531",
  "active_numerator_strength": "50"
}

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