Home NDC 49702-246 Dovato
Product NDC 49702-246
11-digit product format 497020246
Labeler code 49702
Product ID 49702-246_9b88da25-ebce-49ae-8c8a-dcee6f465957
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dolutegravir sodium and lamivudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ViiV Healthcare Company
Application NDA211994
Marketing category NDA
Marketing start 2019-04-08
Substance DOLUTEGRAVIR SODIUM; LAMIVUDINE
Active strength 50; 300 mg/1; mg/1
Pharmacologic classes HIV Integrase Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 N211994-001 DOVATO DOLUTEGRAVIR SODIUM; LAMIVUDINE EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211994-001 8129385 2027-10-05 Drug substance, Drug product 2019-04-24 N211994-001 8129385*PED 2028-04-05 Pediatric extension N211994-001 9242986 2029-12-08 Drug substance, Drug product 2019-04-24 N211994-001 9242986*PED 2030-06-08 Pediatric extension N211994-001 11234985 2031-01-24 U-257 Drug product 2022-02-24
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N211994-001 NPP 2027-04-05
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 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211994-001 DOVATO EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2019-04-08 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 4 · 153 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 N211994-001 8129385 2027-10-05 Drug substance, Drug product 2019-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211994-001 8129385*PED 2028-04-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211994-001 9242986 2029-12-08 Drug substance, Drug product 2019-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211994-001 9242986*PED 2030-06-08 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211994-001 11234985 2031-01-24 U-257 Drug product 2022-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211994-001 8129385 2027-10-05 Drug substance, Drug product 2019-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211994-001 8129385*PED 2028-04-05 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211994-001 9242986 2029-12-08 Drug substance, Drug product 2019-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211994-001 9242986*PED 2030-06-08 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211994-001 11234985 2031-01-24 U-257 Drug product 2022-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211994-001 8129385 2027-10-05 Drug substance, Drug product 2019-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211994-001 8129385*PED 2028-04-05 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211994-001 9242986 2029-12-08 Drug substance, Drug product 2019-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211994-001 9242986*PED 2030-06-08 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211994-001 11234985 2031-01-24 U-257 Drug product 2022-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211994-001 8129385 2027-10-05 Drug substance, Drug product 2019-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211994-001 8129385*PED 2028-04-05 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211994-001 9242986 2029-12-08 Drug substance, Drug product 2019-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211994-001 9242986*PED 2030-06-08 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211994-001 11234985 2031-01-24 U-257 Drug product 2022-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211994-001 8129385 2027-10-05 Drug substance, Drug product 2019-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211994-001 8129385*PED 2028-04-05 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211994-001 9242986 2029-12-08 Drug substance, Drug product 2019-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211994-001 9242986*PED 2030-06-08 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211994-001 11234985 2031-01-24 U-257 Drug product 2022-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211994-001 8129385 2027-10-05 Drug substance, Drug product 2019-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211994-001 8129385*PED 2028-04-05 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211994-001 9242986 2029-12-08 Drug substance, Drug product 2019-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211994-001 9242986*PED 2030-06-08 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211994-001 11234985 2031-01-24 U-257 Drug product 2022-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211994-001 8129385 2027-10-05 Drug substance, Drug product 2019-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211994-001 8129385*PED 2028-04-05 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211994-001 9242986 2029-12-08 Drug substance, Drug product 2019-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211994-001 9242986*PED 2030-06-08 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211994-001 11234985 2031-01-24 U-257 Drug product 2022-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211994-001 8129385 2027-10-05 Drug substance, Drug product 2019-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211994-001 8129385*PED 2028-04-05 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211994-001 9242986 2029-12-08 Drug substance, Drug product 2019-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211994-001 9242986*PED 2030-06-08 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211994-001 11234985 2031-01-24 U-257 Drug product 2022-02-24 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 52 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Dovato
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOLUTEGRAVIR SODIUM 50 mg/1 LAMIVUDINE 300 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 2T8Q726O95 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2122519 Internal RxNorm lookup 2122526 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 49702-246-13 Dovato 30 in 1 BOTTLE TABLET, FILM COATED 30 19 49702-246-33 Dovato 1 in 1 CARTON TABLET, FILM COATED 1 19 49702-246-33 Dovato 30 in 1 BLISTER PACK TABLET, FILM COATED 30 19 49702-246-62 Dovato 14 in 1 BLISTER PACK TABLET, FILM COATED 14 19 49702-246-62 Dovato 1 in 1 CARTON TABLET, FILM COATED 1 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49702-246 DOVATO (DOLUTEGRAVIR SODIUM AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 16 Current NDC, Legacy NDC, 5 package rows 20240921_68e45422-43ed-4cfb-9356-fae88d14a53a.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 Dovato DOLUTEGRAVIR SODIUM AND LAMIVUDINE ViiV Healthcare Company 68e45422-43ed-4cfb-9356-fae88d14a53a 2025-10-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 211994 application number: NDA211994 ndc (product): 49702-246
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49702-246-13 49702024613 30 TABLET, FILM COATED in 1 BOTTLE (49702-246-13) 2019-04-08 0000-00-00 No No Current 49702-246-33 49702024633 1 BLISTER PACK in 1 CARTON (49702-246-33) / 30 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2024-01-01 No No Current 49702-246-61 49702024661 14 TABLET, FILM COATED in 1 BOTTLE (49702-246-61) 2019-08-06 0000-00-00 No No Current 49702-246-62 49702024662 1 BLISTER PACK in 1 CARTON (49702-246-62) / 14 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2024-01-01 No No Current