darunavir 600 and 800 mg

Generic: darunavir

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name darunavir 600 and 800 mg
Generic Name darunavir
Labeler cipla usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

darunavir hydrate 600 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-248
Product ID 69097-248_e3d4803e-30b2-4c8b-90e3-b04c2da4b1c9
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 69097248
Hyphenated Format 69097-248

Supplemental Identifiers

RxCUI
670026 1359269
UPC
0369097248031 0369097244026
UNII
KPC4NRB25L

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

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (69097-248-03)
source: ndc

Packages (1)

69097-248-03 60 TABLET in 1 BOTTLE (69097-248-03)

Ingredients (1)

darunavir hydrate (600 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": "e3d4803e-30b2-4c8b-90e3-b04c2da4b1c9", "openfda": {"upc": ["0369097248031", "0369097244026"], "unii": ["KPC4NRB25L"], "rxcui": ["670026", "1359269"], "spl_set_id": ["5624cc30-d484-458e-b234-9bb745a118ca"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (69097-248-03)", "package_ndc": "69097-248-03", "marketing_start_date": "20231129"}], "brand_name": "Darunavir 600 and 800 mg", "product_id": "69097-248_e3d4803e-30b2-4c8b-90e3-b04c2da4b1c9", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "HIV Protease Inhibitors [MoA]", "Protease Inhibitor [EPC]"], "product_ndc": "69097-248", "generic_name": "darunavir", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darunavir 600 and 800 mg", "active_ingredients": [{"name": "DARUNAVIR HYDRATE", "strength": "600 mg/1"}], "application_number": "ANDA206288", "marketing_category": "ANDA", "marketing_start_date": "20231129", "listing_expiration_date": "20261231"}