FDA.reportPublic FDA data

Juluca

Product NDC
49702-242
11-digit product format
497020242
Labeler code
49702
Product ID
49702-242_155cffa3-1699-44ce-bed2-b1759c1fcf66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dolutegravir sodium and rilpivirine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ViiV Healthcare Company
Application
NDA210192
Marketing category
NDA
Marketing start
2017-11-21
Substance
DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
Active strength
50; 25 mg/1; mg/1
Pharmacologic 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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Juluca
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOLUTEGRAVIR SODIUM50 mg/1
RILPIVIRINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1Q1V9V5WYQ, 212WAX8KDD
Rxcui1989500, 1989506

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33cd1557-9629-1a35-1f2f-499cf7c608bcProduct name220260305
38d19fab-47e8-d825-5329-4948eaa6d686Product name220250124
3832141c-c294-474a-9473-1052c891450eProduct name220230105
f306ec07-0d7d-45ce-ade0-e6c8659560b1Product name120210621
3644e9cf-6f4d-4b63-b875-6a4b5187c47eProduct name120190703
44633898-5724-4273-abcc-3541a1107946Product name120180124
d1784558-3c5f-4d73-8a7c-051102bb6c92Product name120160405
7d3f81af-5024-0cff-2664-d433b7688444Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49702-242-13Juluca30 in 1 BOTTLETABLET, FILM COATED3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49702-242-13EA - Each49702-242d2bafb7a-2eab-4c51-aa06-f754d3b7373a12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49702-242JULUCA (DOLUTEGRAVIR SODIUM AND RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]13Current NDC, Legacy NDC, 1 package rows20250331_806653d1-bf35-4924-b999-ad5d21821cc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1989500dolutegravir 50 MG / rilpivirine 25 MG Oral TabletPSN806653d1-bf35-4924-b999-ad5d21821cc115
1989506Juluca 50 MG / 25 MG Oral TabletPSN806653d1-bf35-4924-b999-ad5d21821cc115
1989506dolutegravir 50 MG / rilpivirine 25 MG Oral Tablet [Juluca]SBD806653d1-bf35-4924-b999-ad5d21821cc115
1989500dolutegravir 50 MG / rilpivirine 25 MG Oral TabletSCD806653d1-bf35-4924-b999-ad5d21821cc115
1989500dolutegravir 50 mg (equivalent to 52.6 mg dolutegravir sodium) / rilpivirine 25 mg (equivalent to 27.5 mg rilpivirine HCl) Oral TabletSY806653d1-bf35-4924-b999-ad5d21821cc115
1989506Juluca (dolutegravir 50 mg (equivalent to 52.6 mg dolutegravir sodium) / rilpivirine 25 mg (equivalent to 27.5 mg rilpivirine HCl)) Oral TabletSY806653d1-bf35-4924-b999-ad5d21821cc115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49702-242-134970202421330 TABLET, FILM COATED in 1 BOTTLE (49702-242-13) 2017-11-210000-00-00NoNoCurrent