Home NDC 49702-242 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210192-001 JULUCA DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210192-001 8129385 2027-10-05 Drug substance, Drug product 2017-12-20 N210192-001 8129385*PED 2028-04-05 Pediatric extension N210192-001 9242986 2029-12-08 Drug substance, Drug product 2017-12-20 N210192-001 9242986*PED 2030-06-08 Pediatric extension N210192-001 10426780 2031-01-24 U-257 Drug substance, Drug product 2019-10-25 N210192-001 12011506 2038-09-05 Drug product 2024-06-26
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 7 · 268 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210192-001 8129385 2027-10-05 Drug substance, Drug product 2017-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210192-001 8129385*PED 2028-04-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210192-001 9242986 2029-12-08 Drug substance, Drug product 2017-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210192-001 9242986*PED 2030-06-08 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210192-001 10426780 2031-01-24 U-257 Drug substance, Drug product 2019-10-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210192-001 12011506 2038-09-05 Drug product 2024-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210192-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2017-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210192-001 8129385 2027-10-05 Drug substance, Drug product 2017-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210192-001 8129385*PED 2028-04-05 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210192-001 9242986 2029-12-08 Drug substance, Drug product 2017-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210192-001 9242986*PED 2030-06-08 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210192-001 10426780 2031-01-24 U-257 Drug substance, Drug product 2019-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210192-001 12011506 2038-09-05 Drug product 2024-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210192-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2017-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210192-001 8129385 2027-10-05 Drug substance, Drug product 2017-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210192-001 8129385*PED 2028-04-05 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210192-001 9242986 2029-12-08 Drug substance, Drug product 2017-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210192-001 9242986*PED 2030-06-08 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210192-001 10426780 2031-01-24 U-257 Drug substance, Drug product 2019-10-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210192-001 12011506 2038-09-05 Drug product 2024-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210192-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2017-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210192-001 8129385 2027-10-05 Drug substance, Drug product 2017-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210192-001 8129385*PED 2028-04-05 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210192-001 9242986 2029-12-08 Drug substance, Drug product 2017-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210192-001 9242986*PED 2030-06-08 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210192-001 10426780 2031-01-24 U-257 Drug substance, Drug product 2019-10-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210192-001 12011506 2038-09-05 Drug product 2024-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210192-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2017-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210192-001 8129385 2027-10-05 Drug substance, Drug product 2017-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210192-001 8129385*PED 2028-04-05 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210192-001 9242986 2029-12-08 Drug substance, Drug product 2017-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210192-001 9242986*PED 2030-06-08 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210192-001 10426780 2031-01-24 U-257 Drug substance, Drug product 2019-10-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210192-001 12011506 2038-09-05 Drug product 2024-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210192-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2017-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210192-001 8129385 2027-10-05 Drug substance, Drug product 2017-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210192-001 8129385*PED 2028-04-05 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210192-001 9242986 2029-12-08 Drug substance, Drug product 2017-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210192-001 9242986*PED 2030-06-08 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210192-001 10426780 2031-01-24 U-257 Drug substance, Drug product 2019-10-25 03ed91905a0d…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Juluca
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOLUTEGRAVIR SODIUM 50 mg/1 RILPIVIRINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1Q1V9V5WYQ Internal UNII lookup 212WAX8KDD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1989500 Internal RxNorm lookup 1989506 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49702-242-13 Juluca 30 in 1 BOTTLE TABLET, FILM COATED 30 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49702-242 JULUCA (DOLUTEGRAVIR SODIUM AND RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 13 Current NDC, Legacy NDC, 1 package rows 20250331_806653d1-bf35-4924-b999-ad5d21821cc1.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Juluca DOLUTEGRAVIR SODIUM AND RILPIVIRINE HYDROCHLORIDE ViiV Healthcare Company 806653d1-bf35-4924-b999-ad5d21821cc1 2025-10-29 Warnings, Adverse reactions Exact identifier application applno (NDA): 210192 application number: NDA210192 ndc (product): 49702-242
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49702-242-13 49702024213 30 TABLET, FILM COATED in 1 BOTTLE (49702-242-13) 2017-11-21 0000-00-00 No No Current