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United States · US · US:70720-101_5de36f8a-cbc2-4884-8fcf-e9302d41c2f8

Varubi

Orange BookUNIIATC A04AD14

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

Identification

ManufacturerTerSera Therapeutics LLC
CountryUS (United States)
ATC codeA04AD14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7072010102
    2 TABLET in 1 BLISTER PACK (70720-101-02)

Annotations

UNII (FDA Substance ID)
57O5S1QSAQ
ROLAPITANT HYDROCHLORIDE
RxCUI 1673367
Orange Book
N206500
Raw payload (JSON)
{
  "unii": {
    "unii": "57O5S1QSAQ",
    "rxcui": "1673367",
    "inchikey": "GZQWMYVDLCUBQX-WVZIYJGPSA-N",
    "display_name": "ROLAPITANT HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "productid": "70720-101_5de36f8a-cbc2-4884-8fcf-e9302d41c2f8",
  "productndc": "70720-101",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206500",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 90MG BASE",
        "product_no": "001",
        "approval_date": "Sep 1, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ROLAPITANT HYDROCHLORIDE",
  "proprietary_name": "Varubi",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA206500",
  "marketing_category": "NDA",
  "nonproprietary_name": "rolapitant",
  "start_marketing_date": "20151007",
  "active_numerator_strength": "90"
}

Related drugs

Other records sharing ATC code A04AD14.

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