prezcobix

Generic: darunavir ethanolate and cobicistat

Labeler: janssen products, lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name prezcobix
Generic Name darunavir ethanolate and cobicistat
Labeler janssen products, lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cobicistat 150 mg/1, darunavir ethanolate 675 mg/1

Identifiers & Regulatory

Product NDC 59676-578
Product ID 59676-578_afe12b96-bf92-4c0a-8cd1-cdd8677b7d32
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205395
Listing Expiration 2027-12-31
Marketing Start 2025-03-21

Pharmacologic Class

Classes
breast cancer resistance protein inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] cytochrome p450 3a inhibitor [epc] cytochrome p450 3a inhibitors [moa] hiv protease 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] protease inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59676578
Hyphenated Format 59676-578

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 prezcobix (source: ndc)
Generic Name darunavir ethanolate and cobicistat (source: ndc)
Application Number NDA205395 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
  • 675 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (59676-578-30)
source: ndc

Packages (1)

59676-578-30 30 TABLET, FILM COATED in 1 BOTTLE (59676-578-30)

Ingredients (2)

cobicistat (150 mg/1) darunavir ethanolate (675 mg/1)

Linked Drug Pages (1)

PREZCOBIX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "afe12b96-bf92-4c0a-8cd1-cdd8677b7d32", "openfda": {}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (59676-578-30)", "package_ndc": "59676-578-30", "marketing_start_date": "20250321"}], "brand_name": "PREZCOBIX", "product_id": "59676-578_afe12b96-bf92-4c0a-8cd1-cdd8677b7d32", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitor [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "HIV Protease 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]", "Protease Inhibitor [EPC]"], "product_ndc": "59676-578", "generic_name": "DARUNAVIR ETHANOLATE and COBICISTAT", "labeler_name": "Janssen Products, LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PREZCOBIX", "active_ingredients": [{"name": "COBICISTAT", "strength": "150 mg/1"}, {"name": "DARUNAVIR ETHANOLATE", "strength": "675 mg/1"}], "application_number": "NDA205395", "marketing_category": "NDA", "marketing_start_date": "20250321", "listing_expiration_date": "20271231"}