Rotarix

UNIISPL

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

Identification

ManufacturerGlaxoSmithKline Biologicals SA

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5816074021
10 APPLICATOR in 1 CARTON (58160-740-21) / 1.5 mL in 1 APPLICATOR (58160-740-02)

Annotations

UNII (FDA Substance ID)

KZ3L01D2PC

HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN

RxCUI 805573

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "KZ3L01D2PC",
    "rxcui": "805573",
    "inchikey": null,
    "display_name": "HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f3182470-1965-4e20-dbaf-e3506f893ea5": {
      "match": "brand_token",
      "title": "ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA]",
      "spl_version": "31",
      "published_date": "2026-03-18"
    }
  },
  "productid": "58160-740_8bc5afc0-e90f-4404-8379-06e456cfd1cc",
  "productndc": "58160-740",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": "HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN",
  "proprietary_name": "Rotarix",
  "active_ingred_unit": "[CCID_50]/mL",
  "application_number": "BLA125265",
  "marketing_category": "BLA",
  "nonproprietary_name": "Rotavirus Vaccine, Live, Oral",
  "start_marketing_date": "20230201",
  "active_numerator_strength": "1000"
}

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