darunavir

Generic: darunavir

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name darunavir
Generic Name darunavir
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

darunavir ethanolate 800 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-346
Product ID 68180-346_f2b03ba0-704c-447a-a7ab-b4eb00243295
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202073
Listing Expiration 2026-12-31
Marketing Start 2023-06-01

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 68180346
Hyphenated Format 68180-346

Supplemental Identifiers

RxCUI
670026 1359269
UPC
0368180345077 0368180346067
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 darunavir (source: ndc)
Generic Name darunavir (source: ndc)
Application Number ANDA202073 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68180-346-06)
source: ndc

Packages (1)

68180-346-06 30 TABLET, FILM COATED in 1 BOTTLE (68180-346-06)

Ingredients (1)

darunavir ethanolate (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": "f2b03ba0-704c-447a-a7ab-b4eb00243295", "openfda": {"upc": ["0368180345077", "0368180346067"], "unii": ["33O78XF0BW"], "rxcui": ["670026", "1359269"], "spl_set_id": ["56daf67e-7501-4cd5-be22-566d7997d42e"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68180-346-06)", "package_ndc": "68180-346-06", "marketing_start_date": "20230601"}], "brand_name": "DARUNAVIR", "product_id": "68180-346_f2b03ba0-704c-447a-a7ab-b4eb00243295", "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": "68180-346", "generic_name": "DARUNAVIR", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DARUNAVIR", "active_ingredients": [{"name": "DARUNAVIR ETHANOLATE", "strength": "800 mg/1"}], "application_number": "ANDA202073", "marketing_category": "ANDA", "marketing_start_date": "20230601", "listing_expiration_date": "20261231"}