darunavir

Generic: darunavir

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name darunavir
Generic Name darunavir
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

darunavir 600 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-1144
Product ID 60219-1144_7fb8acac-13ca-47ca-8b06-d12900d4943b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212493
Listing Expiration 2026-12-31
Marketing Start 2023-12-09

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 602191144
Hyphenated Format 60219-1144

Supplemental Identifiers

RxCUI
670026 1359269
UPC
0360219114463 0360219114531
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 ANDA212493 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (60219-1144-6) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

60219-1144-6 1 BOTTLE, PLASTIC in 1 CARTON (60219-1144-6) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Ingredients (1)

darunavir (600 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": "7fb8acac-13ca-47ca-8b06-d12900d4943b", "openfda": {"nui": ["N0000000246", "N0000175889", "N0000190114", "N0000182137"], "upc": ["0360219114463", "0360219114531"], "unii": ["YO603Y8113"], "rxcui": ["670026", "1359269"], "spl_set_id": ["92b286d5-1ee5-435b-9e1d-2e95c7f2ec69"], "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": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (60219-1144-6)  / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "60219-1144-6", "marketing_start_date": "20231209"}], "brand_name": "Darunavir", "product_id": "60219-1144_7fb8acac-13ca-47ca-8b06-d12900d4943b", "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": "60219-1144", "generic_name": "Darunavir", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darunavir", "active_ingredients": [{"name": "DARUNAVIR", "strength": "600 mg/1"}], "application_number": "ANDA212493", "marketing_category": "ANDA", "marketing_start_date": "20231209", "listing_expiration_date": "20261231"}