tivicay

Generic: dolutegravir sodium

Labeler: viiv healthcare company
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tivicay
Generic Name dolutegravir sodium
Labeler viiv healthcare company
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

dolutegravir sodium 50 mg/1

Manufacturer
ViiV Healthcare Company

Identifiers & Regulatory

Product NDC 49702-228
Product ID 49702-228_a9175b83-2200-4bd2-9ee3-52095b5d2657
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204790
Listing Expiration 2026-12-31
Marketing Start 2013-08-13

Pharmacologic Class

Classes
hiv integrase inhibitors [moa] human immunodeficiency virus integrase strand transfer inhibitor [epc] multidrug and toxin extrusion transporter 1 inhibitors [moa] organic cation transporter 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49702228
Hyphenated Format 49702-228

Supplemental Identifiers

RxCUI
1433873 1433879 1796077 1796079 1796081 1796083 2374562 2374566
UPC
0349702227132 0349702226135 0349702228139
UNII
1Q1V9V5WYQ

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 tivicay (source: ndc)
Generic Name dolutegravir sodium (source: ndc)
Application Number NDA204790 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (49702-228-13)
source: ndc

Packages (1)

49702-228-13 30 TABLET, FILM COATED in 1 BOTTLE (49702-228-13)

Ingredients (1)

dolutegravir sodium (50 mg/1)

Linked Drug Pages (1)

Tivicay, Tivicay PD ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a9175b83-2200-4bd2-9ee3-52095b5d2657", "openfda": {"upc": ["0349702227132", "0349702226135", "0349702228139"], "unii": ["1Q1V9V5WYQ"], "rxcui": ["1433873", "1433879", "1796077", "1796079", "1796081", "1796083", "2374562", "2374566"], "spl_set_id": ["63df5af3-b8ac-4e76-9830-2dbb340af922"], "manufacturer_name": ["ViiV Healthcare Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (49702-228-13)", "package_ndc": "49702-228-13", "marketing_start_date": "20130813"}], "brand_name": "Tivicay", "product_id": "49702-228_a9175b83-2200-4bd2-9ee3-52095b5d2657", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HIV Integrase Inhibitors [MoA]", "Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]", "Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "product_ndc": "49702-228", "generic_name": "dolutegravir sodium", "labeler_name": "ViiV Healthcare Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tivicay", "active_ingredients": [{"name": "DOLUTEGRAVIR SODIUM", "strength": "50 mg/1"}], "application_number": "NDA204790", "marketing_category": "NDA", "marketing_start_date": "20130813", "listing_expiration_date": "20261231"}