prezista

Generic: darunavir

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

Drug Facts

Product Profile

Brand Name prezista
Generic Name darunavir
Labeler janssen products lp
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

darunavir ethanolate 100 mg/mL

Manufacturer
Janssen Products LP

Identifiers & Regulatory

Product NDC 59676-565
Product ID 59676-565_3d80bc62-24ac-c092-e063-6394a90a7bba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202895
Listing Expiration 2026-12-31
Marketing Start 2011-12-16

Pharmacologic Class

Classes
cytochrome p450 2d6 inhibitors [moa] cytochrome p450 3a inhibitors [moa] hiv protease inhibitors [moa] protease inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59676565
Hyphenated Format 59676-565

Supplemental Identifiers

RxCUI
670026 794610 831868 831870 850455 850457 1236628 1236632 1359269 1359271
UPC
0359676563013 0359676562016 0359676564010 0359676566304
UNII
33O78XF0BW

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 prezista (source: ndc)
Generic Name darunavir (source: ndc)
Application Number NDA202895 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (59676-565-01) / 200 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

59676-565-01 1 BOTTLE, GLASS in 1 CARTON (59676-565-01) / 200 mL in 1 BOTTLE, GLASS

Ingredients (1)

darunavir ethanolate (100 mg/mL)

Linked Drug Pages (1)

PREZISTA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3d80bc62-24ac-c092-e063-6394a90a7bba", "openfda": {"upc": ["0359676563013", "0359676562016", "0359676564010", "0359676566304"], "unii": ["33O78XF0BW"], "rxcui": ["670026", "794610", "831868", "831870", "850455", "850457", "1236628", "1236632", "1359269", "1359271"], "spl_set_id": ["814301f9-c990-46a5-b481-2879a521a16f"], "manufacturer_name": ["Janssen Products LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (59676-565-01)  / 200 mL in 1 BOTTLE, GLASS", "package_ndc": "59676-565-01", "marketing_start_date": "20111216"}], "brand_name": "PREZISTA", "product_id": "59676-565_3d80bc62-24ac-c092-e063-6394a90a7bba", "dosage_form": "SUSPENSION", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "HIV Protease Inhibitors [MoA]", "Protease Inhibitor [EPC]"], "product_ndc": "59676-565", "generic_name": "darunavir", "labeler_name": "Janssen Products LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PREZISTA", "active_ingredients": [{"name": "DARUNAVIR ETHANOLATE", "strength": "100 mg/mL"}], "application_number": "NDA202895", "marketing_category": "NDA", "marketing_start_date": "20111216", "listing_expiration_date": "20261231"}