Home NDC 49702-227-13 Tivicay
Product NDC 49702-227
Requested package NDC 49702-227-13
11-digit product format 497020227
Labeler code 49702
Product ID 49702-227_a9175b83-2200-4bd2-9ee3-52095b5d2657
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dolutegravir sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ViiV Healthcare Company
Application NDA204790
Marketing category NDA
Marketing start 2016-06-09
Marketing end 2027-05-31
Substance DOLUTEGRAVIR SODIUM
Active strength 25 mg/1
Pharmacologic 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]
NDC exclude flag No
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204790-001 TIVICAY DOLUTEGRAVIR SODIUM EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 N204790-002 TIVICAY DOLUTEGRAVIR SODIUM EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-06-09 N204790-003 TIVICAY DOLUTEGRAVIR SODIUM EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-06-09
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204790-001 8129385 2027-10-05 Drug substance, Drug product 2013-08-27 N204790-001 8129385*PED 2028-04-05 Pediatric extension N204790-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 N204790-001 9242986*PED 2030-06-08 Pediatric extension N204790-002 8129385 2027-10-05 Drug substance, Drug product 2016-06-15 N204790-002 8129385*PED 2028-04-05 Pediatric extension N204790-002 9242986 2029-12-08 Drug substance, Drug product 2016-06-15 N204790-002 9242986*PED 2030-06-08 Pediatric extension N204790-003 8129385 2027-10-05 Drug substance, Drug product 2016-06-15 N204790-003 8129385*PED 2028-04-05 Pediatric extension N204790-003 9242986 2029-12-08 Drug substance, Drug product 2016-06-15 N204790-003 9242986*PED 2030-06-08 Pediatric extension
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 4 · 123 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 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204790-002 TIVICAY EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204790-003 TIVICAY EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204790-002 TIVICAY EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-06-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204790-003 TIVICAY EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204790-002 TIVICAY EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204790-003 TIVICAY EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204790-002 TIVICAY EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-06-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204790-003 TIVICAY EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204790-002 TIVICAY EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-06-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204790-003 TIVICAY EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204790-002 TIVICAY EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-06-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204790-003 TIVICAY EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204790-002 TIVICAY EQ 10MG BASE TABLET / ORAL RLD 2016-06-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204790-003 TIVICAY EQ 25MG BASE TABLET / ORAL RLD 2016-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204790-002 TIVICAY EQ 10MG BASE TABLET / ORAL RLD 2016-06-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204790-003 TIVICAY EQ 25MG BASE TABLET / ORAL RLD 2016-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204790-002 TIVICAY EQ 10MG BASE TABLET / ORAL RLD 2016-06-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204790-003 TIVICAY EQ 25MG BASE TABLET / ORAL RLD 2016-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204790-002 TIVICAY EQ 10MG BASE TABLET / ORAL RLD 2016-06-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204790-003 TIVICAY EQ 25MG BASE TABLET / ORAL RLD 2016-06-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204790-002 TIVICAY EQ 10MG BASE TABLET / ORAL RLD 2016-06-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204790-003 TIVICAY EQ 25MG BASE TABLET / ORAL RLD 2016-06-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204790-002 TIVICAY EQ 10MG BASE TABLET / ORAL RLD 2016-06-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204790-003 TIVICAY EQ 25MG BASE TABLET / ORAL RLD 2016-06-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204790-002 TIVICAY EQ 10MG BASE TABLET / ORAL RLD 2016-06-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204790-003 TIVICAY EQ 25MG BASE TABLET / ORAL RLD 2016-06-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 10 · 366 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 N204790-001 8129385 2027-10-05 Drug substance, Drug product 2013-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204790-001 8129385*PED 2028-04-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204790-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204790-001 9242986*PED 2030-06-08 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204790-002 8129385 2027-10-05 Drug substance, Drug product 2016-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204790-002 8129385*PED 2028-04-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204790-002 9242986 2029-12-08 Drug substance, Drug product 2016-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204790-002 9242986*PED 2030-06-08 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204790-003 8129385 2027-10-05 Drug substance, Drug product 2016-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204790-003 8129385*PED 2028-04-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204790-003 9242986 2029-12-08 Drug substance, Drug product 2016-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204790-003 9242986*PED 2030-06-08 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204790-001 8129385 2027-10-05 Drug substance, Drug product 2013-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204790-001 8129385*PED 2028-04-05 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204790-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204790-001 9242986*PED 2030-06-08 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204790-002 8129385 2027-10-05 Drug substance, Drug product 2016-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204790-002 8129385*PED 2028-04-05 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204790-002 9242986 2029-12-08 Drug substance, Drug product 2016-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204790-002 9242986*PED 2030-06-08 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204790-003 8129385 2027-10-05 Drug substance, Drug product 2016-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204790-003 8129385*PED 2028-04-05 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204790-003 9242986 2029-12-08 Drug substance, Drug product 2016-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204790-003 9242986*PED 2030-06-08 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204790-001 8129385 2027-10-05 Drug substance, Drug product 2013-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204790-001 8129385*PED 2028-04-05 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204790-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204790-001 9242986*PED 2030-06-08 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204790-002 8129385 2027-10-05 Drug substance, Drug product 2016-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204790-002 8129385*PED 2028-04-05 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204790-002 9242986 2029-12-08 Drug substance, Drug product 2016-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204790-002 9242986*PED 2030-06-08 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204790-003 8129385 2027-10-05 Drug substance, Drug product 2016-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204790-003 8129385*PED 2028-04-05 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204790-003 9242986 2029-12-08 Drug substance, Drug product 2016-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204790-003 9242986*PED 2030-06-08 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204790-001 8129385 2027-10-05 Drug substance, Drug product 2013-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204790-001 8129385*PED 2028-04-05 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204790-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204790-001 9242986*PED 2030-06-08 Pediatric extension fd3edfee7708…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Tivicay Active Ingredients# Ingredient, Strength table Ingredient Strength DOLUTEGRAVIR SODIUM 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1Q1V9V5WYQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1433873 Internal RxNorm lookup 1433879 Internal RxNorm lookup 1796077 Internal RxNorm lookup 1796079 Internal RxNorm lookup 1796081 Internal RxNorm lookup 1796083 Internal RxNorm lookup 2374562 Internal RxNorm lookup 2374566 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 49702-227-13 Tivicay 30 in 1 BOTTLE TABLET, FILM COATED 30 31
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOLUTEGRAVIR SODIUM ACTIVE INGREDIENT 1Q1V9V5WYQ TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 7 DOLUTEGRAVIR ACTIVE MOIETY DKO1W9H7M1 TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 7 MANNITOL INACTIVE INGREDIENT 3OWL53L36A TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 7 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 7 POVIDONES INACTIVE INGREDIENT FZ989GH94E TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 7 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 7 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 7 TALC INACTIVE INGREDIENT 7SEV7J4R1U TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49702-227 TIVICAY PD (DOLUTEGRAVIR SODIUM) TABLET, FOR SUSPENSION TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 29 Current NDC, Legacy NDC, 1 package rows 20240907_63df5af3-b8ac-4e76-9830-2dbb340af922.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 · 2 matching rows.
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 49702-227-13 49702022713 30 TABLET, FILM COATED in 1 BOTTLE (49702-227-13) 2016-06-09 2027-05-31 No No Current