darunavir

Generic: darunavir

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name darunavir
Generic Name darunavir
Labeler zydus lifesciences limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

darunavir 800 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1746
Product ID 70771-1746_1b288e91-dedb-465d-8c45-eb464dc72e89
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214085
Listing Expiration 2026-12-31
Marketing Start 2024-05-01

Pharmacologic Class

Established (EPC)
protease inhibitor [epc]
Mechanism of Action
hiv protease inhibitors [moa] cytochrome p450 3a inhibitors [moa] cytochrome p450 2d6 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711746
Hyphenated Format 70771-1746

Supplemental Identifiers

RxCUI
670026 1359269
UPC
0372578148065
UNII
YO603Y8113
NUI
N0000000246 N0000175889 N0000190114 N0000182137

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 darunavir (source: ndc)
Generic Name darunavir (source: ndc)
Application Number ANDA214085 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (70771-1746-3)
  • 500 TABLET, FILM COATED in 1 BOTTLE (70771-1746-5)
  • 90 TABLET, FILM COATED in 1 BOTTLE (70771-1746-9)
source: ndc

Packages (3)

70771-1746-3 30 TABLET, FILM COATED in 1 BOTTLE (70771-1746-3) 70771-1746-5 500 TABLET, FILM COATED in 1 BOTTLE (70771-1746-5) 70771-1746-9 90 TABLET, FILM COATED in 1 BOTTLE (70771-1746-9)

Ingredients (1)

darunavir (800 mg/1)

Linked Drug Pages (1)

Darunavir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1b288e91-dedb-465d-8c45-eb464dc72e89", "openfda": {"nui": ["N0000000246", "N0000175889", "N0000190114", "N0000182137"], "upc": ["0372578148065"], "unii": ["YO603Y8113"], "rxcui": ["670026", "1359269"], "spl_set_id": ["6a029063-b14c-4eee-9958-0d9eecb27726"], "pharm_class_epc": ["Protease Inhibitor [EPC]"], "pharm_class_moa": ["HIV Protease Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70771-1746-3)", "package_ndc": "70771-1746-3", "marketing_start_date": "20240501"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (70771-1746-5)", "package_ndc": "70771-1746-5", "marketing_start_date": "20240501"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (70771-1746-9)", "package_ndc": "70771-1746-9", "marketing_start_date": "20240501"}], "brand_name": "Darunavir", "product_id": "70771-1746_1b288e91-dedb-465d-8c45-eb464dc72e89", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "HIV Protease Inhibitors [MoA]", "Protease Inhibitor [EPC]"], "product_ndc": "70771-1746", "generic_name": "Darunavir", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darunavir", "active_ingredients": [{"name": "DARUNAVIR", "strength": "800 mg/1"}], "application_number": "ANDA214085", "marketing_category": "ANDA", "marketing_start_date": "20240501", "listing_expiration_date": "20261231"}