prezcobix

Generic: darunavir ethanolate and cobicistat

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name prezcobix
Generic Name darunavir ethanolate and cobicistat
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cobicistat 150 mg/1, darunavir ethanolate 800 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-1723
Product ID 50090-1723_c5bd2c9e-5b7b-4404-bcd2-a82a46da19d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205395
Listing Expiration 2026-12-31
Marketing Start 2015-01-31

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 500901723
Hyphenated Format 50090-1723

Supplemental Identifiers

RxCUI
1600704 1600710
UNII
LW2E03M5PG 33O78XF0BW
NUI
N0000190114 N0000191001 N0000185503 N0000182137 N0000190107 N0000190108 N0000190113 N0000191423

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
  • 800 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-1723-0)
source: ndc

Packages (1)

50090-1723-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-1723-0)

Ingredients (2)

cobicistat (150 mg/1) darunavir ethanolate (800 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": "c5bd2c9e-5b7b-4404-bcd2-a82a46da19d8", "openfda": {"nui": ["N0000190114", "N0000191001", "N0000185503", "N0000182137", "N0000190107", "N0000190108", "N0000190113", "N0000191423"], "unii": ["LW2E03M5PG", "33O78XF0BW"], "rxcui": ["1600704", "1600710"], "spl_set_id": ["16ca460a-3c89-4697-8f45-972615a2a518"], "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": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-1723-0)", "package_ndc": "50090-1723-0", "marketing_start_date": "20150304"}], "brand_name": "PREZCOBIX", "product_id": "50090-1723_c5bd2c9e-5b7b-4404-bcd2-a82a46da19d8", "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": "50090-1723", "generic_name": "DARUNAVIR ETHANOLATE and COBICISTAT", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PREZCOBIX", "active_ingredients": [{"name": "COBICISTAT", "strength": "150 mg/1"}, {"name": "DARUNAVIR ETHANOLATE", "strength": "800 mg/1"}], "application_number": "NDA205395", "marketing_category": "NDA", "marketing_start_date": "20150131", "listing_expiration_date": "20261231"}