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United States · US · US:61958-1401_169d8571-3b28-4b3b-8def-18316f1297f3

Tybost

In shortageOrange BookUNIISPLATC V03AX03

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

Identification

ManufacturerGilead Sciences, Inc.
CountryUS (United States)
ATC codeV03AX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6195814011
    30 TABLET, FILM COATED in 1 BOTTLE (61958-1401-1)

Annotations

UNII (FDA Substance ID)
LW2E03M5PG
COBICISTAT
RxCUI 1306284
Orange Book
N203094
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Cobicistat Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "LW2E03M5PG",
    "rxcui": "1306284",
    "inchikey": "ZCIGNRJZKPOIKD-CQXVEOKZSA-N",
    "display_name": "COBICISTAT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3784c35c-e87f-410c-900b-8fd6313c6010": {
      "match": "brand_token",
      "title": "TYBOST (COBICISTAT) TABLET, FILM COATED [GILEAD SCIENCES, INC.]",
      "spl_version": "16",
      "published_date": "2026-02-18"
    }
  },
  "productid": "61958-1401_169d8571-3b28-4b3b-8def-18316f1297f3",
  "productndc": "61958-1401",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203094",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Sep 24, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "90MG",
        "product_no": "002",
        "approval_date": "Jun 20, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COBICISTAT",
  "shortage_reason": "Cobicistat Tablet",
  "shortage_status": "current",
  "proprietary_name": "Tybost",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA203094",
  "marketing_category": "NDA",
  "nonproprietary_name": "COBICISTAT",
  "start_marketing_date": "20140924",
  "active_numerator_strength": "150"
}

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