Tivicay

Product NDC: 53808-1130
11-digit product format: 538081130
Labeler code: 53808
Product ID: 53808-1130_51db3b9b-9a78-4c16-ad8e-b72fedd6a581
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dolutegravir sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DOH CENTRAL PHARMACY
Application: NDA204790
Marketing category: NDA
Marketing start: 2017-07-10
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: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53808-1130		I	Inactivated by FDA		2026-08-11
excluded package	package	53808-1130	53808-1130-1	I	Inactivated by FDA		2026-08-11

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 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53808-1130-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53808-1130-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53808-1130-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-1130-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-1130-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-1130-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-1130-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-1130-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-1130-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-1130-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-1130-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-1130-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-1130-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-1130-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-1130-1	`1332a3947898…`	`d4bfe170f9cd…`

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	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	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	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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204790-001	I-758	2020-11-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204790-002	I-758	2020-11-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204790-003	I-758	2020-11-21	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N204790-001	I-758	2020-11-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204790-002	I-758	2020-11-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204790-003	I-758	2020-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204790-001	I-758	2020-11-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204790-002	I-758	2020-11-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204790-003	I-758	2020-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204790-001	I-758	2020-11-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204790-002	I-758	2020-11-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204790-003	I-758	2020-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204790-001	I-758	2020-11-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204790-002	I-758	2020-11-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204790-003	I-758	2020-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204790-001	I-758	2020-11-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204790-002	I-758	2020-11-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204790-003	I-758	2020-11-21	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3832141c-c294-474a-9473-1052c891450e	Product name	2	20230105
3644e9cf-6f4d-4b63-b875-6a4b5187c47e	Product name	1	20190703
44633898-5724-4273-abcc-3541a1107946	Product name	1	20180124
7d3f81af-5024-0cff-2664-d433b7688444	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-1130-1	2024-01-30	C162847	48780-1	1030e365-6c40-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use TIVICAY safely and effectively. See full prescribing information for TIVICAY. TIVICAY (dolutegravir tablets), for oral use Initial U.S. Approval: 2013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-1130-1	Tivicay	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-1130	TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20190125_807b0cd2-093c-4353-a4a5-2e1f264616ba.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tivicay	DOLUTEGRAVIR SODIUM	ST. MARY'S MEDICAL PARK PHARMACY	485bc9db-8665-9f5a-e063-6394a90a7921	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204790 application number: NDA204790
Tivicay	DOLUTEGRAVIR SODIUM	ViiV Healthcare Company	63df5af3-b8ac-4e76-9830-2dbb340af922	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204790 application number: NDA204790

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1Q1V9V5WYQ	DOLUTEGRAVIR SODIUM	1051375-19-9	DOLUTEGRAVIR SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1433873	dolutegravir 50 MG Oral Tablet	PSN	807b0cd2-093c-4353-a4a5-2e1f264616ba	1
1433879	Tivicay 50 MG Oral Tablet	PSN	807b0cd2-093c-4353-a4a5-2e1f264616ba	1
1433879	dolutegravir 50 MG Oral Tablet [Tivicay]	SBD	807b0cd2-093c-4353-a4a5-2e1f264616ba	1
1433873	dolutegravir 50 MG Oral Tablet	SCD	807b0cd2-093c-4353-a4a5-2e1f264616ba	1
1433873	dolutegravir 50 MG (as dolutegravir sodium 52.6 MG) Oral Tablet	SY	807b0cd2-093c-4353-a4a5-2e1f264616ba	1
1433879	Tivicay 50 MG (as dolutegravir sodium) Oral Tablet	SY	807b0cd2-093c-4353-a4a5-2e1f264616ba	1
1433879	Tivicay 50 MG Oral Tablet	SY	807b0cd2-093c-4353-a4a5-2e1f264616ba	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53808-1130-1	53808113001	30 TABLET, FILM COATED in 1 BLISTER PACK (53808-1130-1)	2017-07-10	0000-00-00	No	No	Current