Home NDC 60760-748 Tivicay
Product NDC 60760-748
11-digit product format 607600748
Labeler code 60760
Product ID 60760-748_526982bc-f7b7-0c37-e063-6394a90a6d6f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dolutegravir sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ST. MARY'S MEDICAL PARK PHARMACY
Application NDA204790
Marketing category NDA
Marketing start 2013-08-13
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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TIVICAY DOLUTEGRAVIR SODIUM EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-06-09 N204790-003 TIVICAY DOLUTEGRAVIR SODIUM EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-06-09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 · 129 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 2026-09-14 22:38:34 2026-08 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 10 · 390 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N204790-001 8129385 2027-10-05 Drug substance, Drug product 2013-08-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-001 8129385*PED 2028-04-05 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-001 9242986*PED 2030-06-08 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-002 8129385 2027-10-05 Drug substance, Drug product 2016-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-002 8129385*PED 2028-04-05 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-002 9242986 2029-12-08 Drug substance, Drug product 2016-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-002 9242986*PED 2030-06-08 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-003 8129385 2027-10-05 Drug substance, Drug product 2016-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-003 8129385*PED 2028-04-05 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-003 9242986 2029-12-08 Drug substance, Drug product 2016-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-003 9242986*PED 2030-06-08 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204790-001 8129385 2027-10-05 Drug substance, Drug product 2013-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-001 8129385*PED 2028-04-05 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-001 9242986*PED 2030-06-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-002 8129385 2027-10-05 Drug substance, Drug product 2016-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-002 8129385*PED 2028-04-05 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-002 9242986 2029-12-08 Drug substance, Drug product 2016-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-002 9242986*PED 2030-06-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-003 8129385 2027-10-05 Drug substance, Drug product 2016-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-003 8129385*PED 2028-04-05 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-003 9242986 2029-12-08 Drug substance, Drug product 2016-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-003 9242986*PED 2030-06-08 Pediatric extension caaa826d4ba7…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…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Tivicay
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOLUTEGRAVIR SODIUM 50 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1433873 Internal RxNorm lookup 1433879 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 60760-748-07 Tivicay 7 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 7 2
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 Sample Exclude flag Status 60760-748-07 60760074807 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-748-07) 2026-01-16 No No Current