juluca

Generic: dolutegravir sodium and rilpivirine hydrochloride

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

Drug Facts

Product Profile

Brand Name juluca
Generic Name dolutegravir sodium and rilpivirine hydrochloride
Labeler viiv healthcare company
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

dolutegravir sodium 50 mg/1, rilpivirine hydrochloride 25 mg/1

Manufacturer
ViiV Healthcare Company

Identifiers & Regulatory

Product NDC 49702-242
Product ID 49702-242_155cffa3-1699-44ce-bed2-b1759c1fcf66
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210192
Listing Expiration 2026-12-31
Marketing Start 2017-11-21

Pharmacologic Class

Classes
hiv integrase inhibitors [moa] human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitor [epc] human immunodeficiency virus integrase strand transfer inhibitor [epc] multidrug and toxin extrusion transporter 1 inhibitors [moa] non-nucleoside analog [ext] non-nucleoside reverse transcriptase inhibitors [moa] organic cation transporter 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49702242
Hyphenated Format 49702-242

Supplemental Identifiers

RxCUI
1989500 1989506
UNII
1Q1V9V5WYQ 212WAX8KDD

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 juluca (source: ndc)
Generic Name dolutegravir sodium and rilpivirine hydrochloride (source: ndc)
Application Number NDA210192 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (49702-242-13)
source: ndc

Packages (1)

49702-242-13 30 TABLET, FILM COATED in 1 BOTTLE (49702-242-13)

Ingredients (2)

dolutegravir sodium (50 mg/1) rilpivirine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Juluca ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "155cffa3-1699-44ce-bed2-b1759c1fcf66", "openfda": {"unii": ["1Q1V9V5WYQ", "212WAX8KDD"], "rxcui": ["1989500", "1989506"], "spl_set_id": ["806653d1-bf35-4924-b999-ad5d21821cc1"], "manufacturer_name": ["ViiV Healthcare Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (49702-242-13)", "package_ndc": "49702-242-13", "marketing_start_date": "20171121"}], "brand_name": "Juluca", "product_id": "49702-242_155cffa3-1699-44ce-bed2-b1759c1fcf66", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HIV Integrase Inhibitors [MoA]", "Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]", "Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]", "Non-Nucleoside Analog [EXT]", "Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "product_ndc": "49702-242", "generic_name": "dolutegravir sodium and rilpivirine hydrochloride", "labeler_name": "ViiV Healthcare Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Juluca", "active_ingredients": [{"name": "DOLUTEGRAVIR SODIUM", "strength": "50 mg/1"}, {"name": "RILPIVIRINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "NDA210192", "marketing_category": "NDA", "marketing_start_date": "20171121", "listing_expiration_date": "20261231"}