Tivicay PD

Product NDC: 49702-255
11-digit product format: 497020255
Labeler code: 49702
Product ID: 49702-255_a9175b83-2200-4bd2-9ee3-52095b5d2657
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dolutegravir sodium
Dosage form: TABLET, FOR SUSPENSION
Route: ORAL
Labeler: ViiV Healthcare Company
Application: NDA213983
Marketing category: NDA
Marketing start: 2020-06-12
Substance: DOLUTEGRAVIR SODIUM
Active strength: 5 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: 2026-12-31
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
N213983-001	TIVICAY PD	DOLUTEGRAVIR SODIUM	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2020-06-12

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N213983-001	8129385	2027-10-05	Drug substance, Drug product	2020-06-19
N213983-001	8129385*PED	2028-04-05	Pediatric extension
N213983-001	9242986	2029-12-08	Drug substance, Drug product	2020-06-19
N213983-001	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.

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	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213983-001	TIVICAY PD	EQ 5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2020-06-12	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 114 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	N213983-001	8129385	2027-10-05	Drug substance, Drug product	2020-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213983-001	8129385*PED	2028-04-05	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213983-001	9242986	2029-12-08	Drug substance, Drug product	2020-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213983-001	9242986*PED	2030-06-08	Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213983-001	8129385	2027-10-05	Drug substance, Drug product	2020-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213983-001	8129385*PED	2028-04-05	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213983-001	9242986	2029-12-08	Drug substance, Drug product	2020-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213983-001	9242986*PED	2030-06-08	Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213983-001	8129385	2027-10-05	Drug substance, Drug product	2020-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213983-001	8129385*PED	2028-04-05	Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213983-001	9242986	2029-12-08	Drug substance, Drug product	2020-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213983-001	9242986*PED	2030-06-08	Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213983-001	8129385	2027-10-05	Drug substance, Drug product	2020-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213983-001	8129385*PED	2028-04-05	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213983-001	9242986	2029-12-08	Drug substance, Drug product	2020-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213983-001	9242986*PED	2030-06-08	Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213983-001	8129385	2027-10-05	Drug substance, Drug product	2020-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213983-001	8129385*PED	2028-04-05	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213983-001	9242986	2029-12-08	Drug substance, Drug product	2020-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213983-001	9242986*PED	2030-06-08	Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213983-001	8129385	2027-10-05	Drug substance, Drug product	2020-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213983-001	8129385*PED	2028-04-05	Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213983-001	9242986	2029-12-08	Drug substance, Drug product	2020-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213983-001	9242986*PED	2030-06-08	Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213983-001	8129385	2027-10-05	Drug substance, Drug product	2020-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213983-001	8129385*PED	2028-04-05	Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213983-001	9242986	2029-12-08	Drug substance, Drug product	2020-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213983-001	9242986*PED	2030-06-08	Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213983-001	8129385	2027-10-05	Drug substance, Drug product	2020-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213983-001	8129385*PED	2028-04-05	Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213983-001	9242986	2029-12-08	Drug substance, Drug product	2020-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213983-001	9242986*PED	2030-06-08	Pediatric extension		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213983-001	8129385	2027-10-05	Drug substance, Drug product	2020-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213983-001	8129385*PED	2028-04-05	Pediatric extension		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213983-001	9242986	2029-12-08	Drug substance, Drug product	2020-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213983-001	9242986*PED	2030-06-08	Pediatric extension		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213983-001	8129385	2027-10-05	Drug substance, Drug product	2020-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213983-001	8129385*PED	2028-04-05	Pediatric extension		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213983-001	9242986	2029-12-08	Drug substance, Drug product	2020-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213983-001	9242986*PED	2030-06-08	Pediatric extension		`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tivicay PD
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOLUTEGRAVIR SODIUM	5 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
63df5af3-b8ac-4e76-9830-2dbb340af922	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49702-255-37	Tivicay PD	60 in 1 BOTTLE	TABLET, FOR SUSPENSION	60		31
49702-255-37	Tivicay PD	1 in 1 CARTON	TABLET, FOR SUSPENSION	1		31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49702-255-37	EA - Each	49702-255	fbbbc9ca-1048-4228-999d-225e0ab6fb82	1	2020-07-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
49702-255	TIVICAY PD (DOLUTEGRAVIR SODIUM) TABLET, FOR SUSPENSION TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]	29	Current NDC, Legacy NDC, 2 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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tivicay	DOLUTEGRAVIR SODIUM	ViiV Healthcare Company	63df5af3-b8ac-4e76-9830-2dbb340af922	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213983 application number: NDA213983 ndc (product): 49702-255

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
1796077	dolutegravir 10 MG Oral Tablet	PSN	63df5af3-b8ac-4e76-9830-2dbb340af922	31
1796081	dolutegravir 25 MG Oral Tablet	PSN	63df5af3-b8ac-4e76-9830-2dbb340af922	31
2374562	dolutegravir 5 MG Tablet for Oral Suspension	PSN	63df5af3-b8ac-4e76-9830-2dbb340af922	31
1433873	dolutegravir 50 MG Oral Tablet	PSN	63df5af3-b8ac-4e76-9830-2dbb340af922	31
1796079	Tivicay 10 MG Oral Tablet	PSN	63df5af3-b8ac-4e76-9830-2dbb340af922	31
1796083	Tivicay 25 MG Oral Tablet	PSN	63df5af3-b8ac-4e76-9830-2dbb340af922	31
1433879	Tivicay 50 MG Oral Tablet	PSN	63df5af3-b8ac-4e76-9830-2dbb340af922	31
2374566	Tivicay PD 5 MG Tablet for Oral Suspension	PSN	63df5af3-b8ac-4e76-9830-2dbb340af922	31
1796079	dolutegravir 10 MG Oral Tablet [Tivicay]	SBD	63df5af3-b8ac-4e76-9830-2dbb340af922	31
1796083	dolutegravir 25 MG Oral Tablet [Tivicay]	SBD	63df5af3-b8ac-4e76-9830-2dbb340af922	31
2374566	dolutegravir 5 MG Tablet for Oral Suspension [Tivicay]	SBD	63df5af3-b8ac-4e76-9830-2dbb340af922	31
1433879	dolutegravir 50 MG Oral Tablet [Tivicay]	SBD	63df5af3-b8ac-4e76-9830-2dbb340af922	31
1796077	dolutegravir 10 MG Oral Tablet	SCD	63df5af3-b8ac-4e76-9830-2dbb340af922	31
1796081	dolutegravir 25 MG Oral Tablet	SCD	63df5af3-b8ac-4e76-9830-2dbb340af922	31
2374562	dolutegravir 5 MG Tablet for Oral Suspension	SCD	63df5af3-b8ac-4e76-9830-2dbb340af922	31
1433873	dolutegravir 50 MG Oral Tablet	SCD	63df5af3-b8ac-4e76-9830-2dbb340af922	31
1796077	dolutegravir 10 MG (as dolutegravir sodium) Oral Tablet	SY	63df5af3-b8ac-4e76-9830-2dbb340af922	31
1796081	dolutegravir 25 MG (as dolutegravir sodium) Oral Tablet	SY	63df5af3-b8ac-4e76-9830-2dbb340af922	31
2374562	dolutegravir 5 MG (as dolutegravir sodium) Tablet for Oral Suspension	SY	63df5af3-b8ac-4e76-9830-2dbb340af922	31
1433873	dolutegravir 50 MG (as dolutegravir sodium 52.6 MG) Oral Tablet	SY	63df5af3-b8ac-4e76-9830-2dbb340af922	31
1796079	Tivicay 10 MG (as dolutegravir sodium) Oral Tablet	SY	63df5af3-b8ac-4e76-9830-2dbb340af922	31
1796083	Tivicay 25 MG (as dolutegravir sodium) Oral Tablet	SY	63df5af3-b8ac-4e76-9830-2dbb340af922	31
1433879	Tivicay 50 MG (as dolutegravir sodium) Oral Tablet	SY	63df5af3-b8ac-4e76-9830-2dbb340af922	31
1433879	Tivicay 50 MG Oral Tablet	SY	63df5af3-b8ac-4e76-9830-2dbb340af922	31
2374566	Tivicay PD 5 MG (as dolutegravir sodium) Tablet for Oral Suspension	SY	63df5af3-b8ac-4e76-9830-2dbb340af922	31
2374566	Tivicay PD 5 MG Tablet for Oral Suspension	SY	63df5af3-b8ac-4e76-9830-2dbb340af922	31

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49702-255-37	49702025537	1 BOTTLE in 1 CARTON (49702-255-37) / 60 TABLET, FOR SUSPENSION in 1 BOTTLE	1 bottle	2020-06-12	0000-00-00	No	No	Current