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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
- ndc11619581401130 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"
}Related drugs
Other records sharing ATC code V03AX03.
- FITybostGilead Sciences Ireland UC
- PLTybostGilead Sciences Ireland UC
- DKTybostGilead Sciences Ireland UC
- CZTYBOSTGilead Sciences Ireland UC, Carrigtohill
- CZTYBOSTGilead Sciences Ireland UC, Carrigtohill
- BETybost 150 mgGilead Sciences Ireland UC
- IETybost 150 mg film-coated tabletsGilead Sciences Ireland UC
- NLTybost 150 mg filmomhulde tablettenGilead Sciences Ireland UC
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