Home NDC 70518-1487-0 Tivicay
Product NDC 70518-1487
Requested package NDC 70518-1487-0
11-digit product format 705181487
Labeler code 70518
Product ID 70518-1487_d9646621-c67e-490a-e053-2995a90a2a4e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dolutegravir sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA204790
Marketing category NDA
Marketing start 2018-10-06
Marketing end 0000-00-00
Substance DOLUTEGRAVIR SODIUM
Active strength 50 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
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70518-1487-0 70518148700 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1487-0) 2018-10-06 0000-00-00 No No Current