darunavir

Generic: darunavir

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

Drug Facts

Product Profile

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

darunavir 800 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-089
Product ID 31722-089_30b10990-92c4-531b-e063-6294a90a7a27
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216168
Listing Expiration 2026-12-31
Marketing Start 2025-01-21

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 31722089
Hyphenated Format 31722-089

Supplemental Identifiers

RxCUI
670026 1359269
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 ANDA216168 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (31722-089-30)
source: ndc

Packages (1)

31722-089-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-089-30)

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": "30b10990-92c4-531b-e063-6294a90a7a27", "openfda": {"nui": ["N0000000246", "N0000175889", "N0000190114", "N0000182137"], "unii": ["YO603Y8113"], "rxcui": ["670026", "1359269"], "spl_set_id": ["49606d5e-f45f-45eb-9ab8-15aa6a233875"], "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": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (31722-089-30)", "package_ndc": "31722-089-30", "marketing_start_date": "20250121"}], "brand_name": "Darunavir", "product_id": "31722-089_30b10990-92c4-531b-e063-6294a90a7a27", "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": "31722-089", "generic_name": "Darunavir", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darunavir", "active_ingredients": [{"name": "DARUNAVIR", "strength": "800 mg/1"}], "application_number": "ANDA216168", "marketing_category": "ANDA", "marketing_start_date": "20250121", "listing_expiration_date": "20261231"}