Rukobia

Product NDC: 49702-250
11-digit product format: 497020250
Labeler code: 49702
Product ID: 49702-250_9a0bc98a-3305-43f1-85bf-fb1e9ba88d45
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fostemsavir tromethamine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: ViiV Healthcare Company
Application: NDA212950
Marketing category: NDA
Marketing start: 2020-07-02
Substance: FOSTEMSAVIR TROMETHAMINE
Active strength: 600 mg/1
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 43.

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
N212950-001	RUKOBIA	FOSTEMSAVIR TROMETHAMINE	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2020-07-02

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212950-001	7745625	2027-11-19		Drug substance	2020-07-17
N212950-001	8168615	2029-07-13		Drug product	2020-07-17

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
2026-09-14 22:38:34	2026-08	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212950-001	RUKOBIA	EQ 600MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-07-02	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 113 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N212950-001	7745625	2027-11-19	Drug substance	2020-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212950-001	8168615	2029-07-13	Drug product	2020-07-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212950-001	7745625	2027-11-19	Drug substance	2020-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212950-001	8168615	2029-07-13	Drug product	2020-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212950-001	7745625	2027-11-19	Drug substance	2020-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212950-001	8168615	2029-07-13	Drug product	2020-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212950-001	8461333	2025-02-25	Drug substance	2020-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212950-001	7745625	2027-11-19	Drug substance	2020-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212950-001	8168615	2029-07-13	Drug product	2020-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212950-001	8461333	2025-02-25	Drug substance	2020-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212950-001	7745625	2027-11-19	Drug substance	2020-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212950-001	8168615	2029-07-13	Drug product	2020-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212950-001	8461333	2025-02-25	Drug substance	2020-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212950-001	7745625	2027-11-19	Drug substance	2020-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212950-001	8168615	2029-07-13	Drug product	2020-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212950-001	8461333	2025-02-25	Drug substance	2020-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212950-001	7745625	2027-11-19	Drug substance	2020-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212950-001	8168615	2029-07-13	Drug product	2020-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212950-001	8461333	2025-02-25	Drug substance	2020-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212950-001	7745625	2027-11-19	Drug substance	2020-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212950-001	8168615	2029-07-13	Drug product	2020-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212950-001	8461333	2025-02-25	Drug substance	2020-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212950-001	7745625	2027-11-19	Drug substance	2020-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212950-001	8168615	2029-07-13	Drug product	2020-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212950-001	8461333	2025-02-25	Drug substance	2020-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212950-001	7745625	2027-11-19	Drug substance	2020-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212950-001	8168615	2029-07-13	Drug product	2020-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212950-001	8461333	2025-02-25	Drug substance	2020-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212950-001	7745625	2027-11-19	Drug substance	2020-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212950-001	8168615	2029-07-13	Drug product	2020-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212950-001	8461333	2025-02-25	Drug substance	2020-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212950-001	7745625	2027-11-19	Drug substance	2020-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212950-001	8168615	2029-07-13	Drug product	2020-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212950-001	8461333	2025-02-25	Drug substance	2020-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212950-001	7745625	2027-11-19	Drug substance	2020-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212950-001	8168615	2029-07-13	Drug product	2020-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212950-001	8461333	2025-02-25	Drug substance	2020-07-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212950-001	7745625	2027-11-19	Drug substance	2020-07-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212950-001	8168615	2029-07-13	Drug product	2020-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212950-001	8461333	2025-02-25	Drug substance	2020-07-17	`1e350fbaab3a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212950-001	NCE	2025-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212950-001	NCE	2025-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212950-001	NCE	2025-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212950-001	NCE	2025-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212950-001	NCE	2025-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212950-001	NCE	2025-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212950-001	NCE	2025-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212950-001	NCE	2025-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212950-001	NCE	2025-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212950-001	NCE	2025-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212950-001	NCE	2025-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212950-001	NCE	2025-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212950-001	NCE	2025-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212950-001	NCE	2025-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212950-001	NCE	2025-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212950-001	NCE	2025-07-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212950-001	NCE	2025-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212950-001	NCE	2025-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212950-001	NCE	2025-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212950-001	NCE	2025-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212950-001	NCE	2025-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212950-001	NCE	2025-07-02	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212950-001	NCE	2025-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212950-001	NCE	2025-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212950-001	NCE	2025-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212950-001	NCE	2025-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212950-001	NCE	2025-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212950-001	NCE	2025-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212950-001	NCE	2025-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212950-001	NCE	2025-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212950-001	NCE	2025-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212950-001	NCE	2025-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212950-001	NCE	2025-07-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212950-001	NCE	2025-07-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212950-001	NCE	2025-07-02	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FOSTEMSAVIR TROMETHAMINE	600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2X513P36U0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2380549	Internal RxNorm lookup
2380551	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
a21006b7-6d6f-4f06-81b4-17978756452b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7b2c5f20-df5e-444f-86fd-d6e77e7ca52c	Product name	1	20210119

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49702-250-18	Rukobia	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60		8
49702-250-18	Rukobia	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49702-250-18	EA - Each	49702-250	66fe04c5-dbd1-4070-b2d0-d38b96ee7a85	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49702-250	RUKOBIA (FOSTEMSAVIR TROMETHAMINE) TABLET, FILM COATED, EXTENDED RELEASE [VIIV HEALTHCARE COMPANY]	7	Current NDC, Legacy NDC, 2 package rows	20240616_a21006b7-6d6f-4f06-81b4-17978756452b.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
Rukobia	FOSTEMSAVIR TROMETHAMINE	ViiV Healthcare Company	a21006b7-6d6f-4f06-81b4-17978756452b	2024-02-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212950 application number: NDA212950 ndc (product): 49702-250

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2X513P36U0	FOSTEMSAVIR TROMETHAMINE	864953-39-9	FOSTEMSAVIR TROMETHAMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2380549	fostemsavir 600 MG 12HR Extended Release Oral Tablet	PSN	a21006b7-6d6f-4f06-81b4-17978756452b	8
2380551	Rukobia 600 MG 12HR Extended Release Oral Tablet	PSN	a21006b7-6d6f-4f06-81b4-17978756452b	8
2380551	12 HR fostemsavir 600 MG Extended Release Oral Tablet [Rukobia]	SBD	a21006b7-6d6f-4f06-81b4-17978756452b	8
2380549	12 HR fostemsavir 600 MG Extended Release Oral Tablet	SCD	a21006b7-6d6f-4f06-81b4-17978756452b	8
2380549	12 HR fostemsavir 600 MG (equivalent to 725 MG fostemsavir tromethamine) Extended Release Oral Tablet	SY	a21006b7-6d6f-4f06-81b4-17978756452b	8
2380551	12 HR fostemsavir 600 MG (equivalent to 725 MG fostemsavir tromethamine) Extended Release Oral Tablet [Rukobia]	SY	a21006b7-6d6f-4f06-81b4-17978756452b	8
2380549	fostemsavir 600 MG 12 HR Extended Release Oral Tablet	SY	a21006b7-6d6f-4f06-81b4-17978756452b	8
2380551	Rukobia 600 MG 12 HR Extended Release Oral Tablet	SY	a21006b7-6d6f-4f06-81b4-17978756452b	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49702-250-18	49702025018	1 BOTTLE in 1 CARTON (49702-250-18) / 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2020-07-02	0000-00-00	No	No	Current