Back to search
🇺🇸

United States · US · US:61958-1201_65c2d2eb-d180-41c3-b346-9cdc6e52d5ed

Stribild

Orange BookUNIISPLATC V03AX

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

Identification

ManufacturerGilead Sciences, Inc.
CountryUS (United States)
ATC codeV03AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6195812011
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1201-1)

Annotations

UNII (FDA Substance ID)
LW2E03M5PG
COBICISTAT
RxCUI 1306284
Orange Book
N203100
DailyMed SPL labels
1 version tracked
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": {
    "74ae2a93-b267-444c-8f0f-a2a6522260ee": {
      "match": "brand_token",
      "title": "STRIBILD (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]",
      "spl_version": "22",
      "published_date": "2025-02-14"
    }
  },
  "productid": "61958-1201_65c2d2eb-d180-41c3-b346-9cdc6e52d5ed",
  "productndc": "61958-1201",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203100",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "150MG;150MG;200MG;300MG",
        "product_no": "001",
        "approval_date": "Aug 27, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
  "proprietary_name": "Stribild",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "NDA203100",
  "marketing_category": "NDA",
  "nonproprietary_name": "elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate",
  "start_marketing_date": "20120827",
  "active_numerator_strength": "150; 150; 200; 300"
}

Related drugs

Other records sharing ATC code V03AX.

Access this data programmatically

Query Stribild and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.