tybost

Generic: cobicistat

Labeler: gilead sciences, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tybost
Generic Name cobicistat
Labeler gilead sciences, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cobicistat 150 mg/1

Manufacturer
Gilead Sciences, Inc.

Identifiers & Regulatory

Product NDC 61958-1401
Product ID 61958-1401_169d8571-3b28-4b3b-8def-18316f1297f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203094
Marketing Start 2014-09-24
Marketing End 2028-03-31

Pharmacologic Class

Established (EPC)
cytochrome p450 3a inhibitor [epc]
Mechanism of Action
cytochrome p450 3a inhibitors [moa] p-glycoprotein inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] organic anion transporting polypeptide 1b1 inhibitors [moa] organic anion transporting polypeptide 1b3 inhibitors [moa] breast cancer resistance protein inhibitors [moa] multidrug and toxin extrusion transporter 1 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 619581401
Hyphenated Format 61958-1401

Supplemental Identifiers

RxCUI
1551993 1551999 2719618 2719620
UNII
LW2E03M5PG
NUI
N0000190114 N0000191001 N0000185503 N0000182137 N0000190107 N0000190108 N0000190113 N0000191423

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tybost (source: ndc)
Generic Name cobicistat (source: ndc)
Application Number NDA203094 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (61958-1401-1)
source: ndc

Packages (1)

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

Ingredients (1)

cobicistat (150 mg/1)

Linked Drug Pages (1)

Tybost ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "169d8571-3b28-4b3b-8def-18316f1297f3", "openfda": {"nui": ["N0000190114", "N0000191001", "N0000185503", "N0000182137", "N0000190107", "N0000190108", "N0000190113", "N0000191423"], "unii": ["LW2E03M5PG"], "rxcui": ["1551993", "1551999", "2719618", "2719620"], "spl_set_id": ["3784c35c-e87f-410c-900b-8fd6313c6010"], "pharm_class_epc": ["Cytochrome P450 3A Inhibitor [EPC]"], "pharm_class_moa": ["Cytochrome P450 3A Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]"], "manufacturer_name": ["Gilead Sciences, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (61958-1401-1)", "package_ndc": "61958-1401-1", "marketing_end_date": "20280331", "marketing_start_date": "20140924"}], "brand_name": "Tybost", "product_id": "61958-1401_169d8571-3b28-4b3b-8def-18316f1297f3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitor [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "61958-1401", "generic_name": "COBICISTAT", "labeler_name": "Gilead Sciences, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tybost", "active_ingredients": [{"name": "COBICISTAT", "strength": "150 mg/1"}], "application_number": "NDA203094", "marketing_category": "NDA", "marketing_end_date": "20280331", "marketing_start_date": "20140924"}