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United States · US · US:49702-250_9a0bc98a-3305-43f1-85bf-fb1e9ba88d45

Rukobia

Orange BookUNIISPLATC J05AX

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerViiV Healthcare Company
CountryUS (United States)
ATC codeJ05AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4970225018
    1 BOTTLE in 1 CARTON (49702-250-18) / 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
2X513P36U0
FOSTEMSAVIR TROMETHAMINE
RxCUI 2380374
Orange Book
N212950
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2X513P36U0",
    "rxcui": "2380374",
    "inchikey": "RRGJSMBMTOKHTE-UHFFFAOYSA-N",
    "display_name": "FOSTEMSAVIR TROMETHAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a21006b7-6d6f-4f06-81b4-17978756452b": {
      "match": "brand_token",
      "title": "RUKOBIA (FOSTEMSAVIR TROMETHAMINE) TABLET, FILM COATED, EXTENDED RELEASE [VIIV HEALTHCARE COMPANY]",
      "spl_version": "8",
      "published_date": "2025-06-12"
    }
  },
  "productid": "49702-250_9a0bc98a-3305-43f1-85bf-fb1e9ba88d45",
  "productndc": "49702-250",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "212950",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 600MG BASE",
        "product_no": "001",
        "approval_date": "Jul 2, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FOSTEMSAVIR TROMETHAMINE",
  "proprietary_name": "Rukobia",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA212950",
  "marketing_category": "NDA",
  "nonproprietary_name": "fostemsavir tromethamine",
  "start_marketing_date": "20200702",
  "active_numerator_strength": "600"
}

Related drugs

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