darunavir 600 and 800 mg

Generic: darunavir

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name darunavir 600 and 800 mg
Generic Name darunavir
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

darunavir dihydrate 800 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-5686
Product ID 63629-5686_290dd3c3-c6b7-415f-99b3-680080281b30
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206288
Listing Expiration 2026-12-31
Marketing Start 2023-11-29

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 636295686
Hyphenated Format 63629-5686

Supplemental Identifiers

RxCUI
1359269
UNII
KPC4NRB25L

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 600 and 800 mg (source: ndc)
Generic Name darunavir (source: ndc)
Application Number ANDA206288 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (63629-5686-1)
source: ndc

Packages (1)

63629-5686-1 15 TABLET in 1 BOTTLE (63629-5686-1)

Ingredients (1)

darunavir dihydrate (800 mg/1)

Linked Drug Pages (1)

Darunavir 600 and 800 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "290dd3c3-c6b7-415f-99b3-680080281b30", "openfda": {"unii": ["KPC4NRB25L"], "rxcui": ["1359269"], "spl_set_id": ["bf99d8b8-c4e0-4cb4-924e-8cdcfd8d1aa1"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (63629-5686-1)", "package_ndc": "63629-5686-1", "marketing_start_date": "20250605"}], "brand_name": "Darunavir 600 and 800 mg", "product_id": "63629-5686_290dd3c3-c6b7-415f-99b3-680080281b30", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "HIV Protease Inhibitors [MoA]", "Protease Inhibitor [EPC]"], "product_ndc": "63629-5686", "generic_name": "darunavir", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darunavir 600 and 800 mg", "active_ingredients": [{"name": "DARUNAVIR DIHYDRATE", "strength": "800 mg/1"}], "application_number": "ANDA206288", "marketing_category": "ANDA", "marketing_start_date": "20231129", "listing_expiration_date": "20261231"}