Varubi

Product NDC: 87628-101
Requested package NDC: 87628-101-02
11-digit product format: 876280101
Labeler code: 87628
Product ID: 87628-101_25c6e790-1e90-4901-b85b-f24d2c8c2b04
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rolapitant
Dosage form: TABLET
Route: ORAL
Labeler: Luria Therapeutics LLC
Application: NDA206500
Marketing category: NDA
Marketing start: 2026-08-20
Substance: ROLAPITANT HYDROCHLORIDE
Active strength: 90 mg/1
Pharmacologic classes: Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], P-Glycoprotein Inhibitors [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]
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 44.

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
N206500-001	VARUBI	ROLAPITANT HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL		RLD, RS	2015-09-01

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206500-001	7563801	2027-04-04		Drug product	2015-09-25
N206500-001	7981905	2027-04-04	U-1741		2015-09-25
N206500-001	8178550	2027-04-04		Drug substance, Drug product	2015-09-25
N206500-001	8404702	2027-04-04	U-1741		2015-09-25
N206500-001	7049320	2028-08-19	U-1741	Drug substance, Drug product	2015-09-25
N206500-001	8470842	2029-01-18	U-1741		2015-09-25
N206500-001	8361500	2029-10-09		Drug product	2015-09-25

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206500-001	VARUBI	EQ 90MG BASE	TABLET / ORAL	RLD, RS	2015-09-01	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 326 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N206500-001	7563801	2027-04-04		Drug product	2015-09-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206500-001	7981905	2027-04-04	U-1741		2015-09-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206500-001	8178550	2027-04-04		Drug substance, Drug product	2015-09-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206500-001	8404702	2027-04-04	U-1741		2015-09-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206500-001	7049320	2028-08-19	U-1741	Drug substance, Drug product	2015-09-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206500-001	8470842	2029-01-18	U-1741		2015-09-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206500-001	8361500	2029-10-09		Drug product	2015-09-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N206500-001	7563801	2027-04-04		Drug product	2015-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206500-001	7981905	2027-04-04	U-1741		2015-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206500-001	8178550	2027-04-04		Drug substance, Drug product	2015-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206500-001	8404702	2027-04-04	U-1741		2015-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206500-001	7049320	2028-08-19	U-1741	Drug substance, Drug product	2015-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206500-001	8470842	2029-01-18	U-1741		2015-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206500-001	8361500	2029-10-09		Drug product	2015-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206500-001	7563801	2027-04-04		Drug product	2015-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206500-001	7981905	2027-04-04	U-1741		2015-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206500-001	8178550	2027-04-04		Drug substance, Drug product	2015-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206500-001	8404702	2027-04-04	U-1741		2015-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206500-001	7049320	2028-08-19	U-1741	Drug substance, Drug product	2015-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206500-001	8470842	2029-01-18	U-1741		2015-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206500-001	8361500	2029-10-09		Drug product	2015-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206500-001	7563801	2027-04-04		Drug product	2015-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206500-001	7981905	2027-04-04	U-1741		2015-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206500-001	8178550	2027-04-04		Drug substance, Drug product	2015-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206500-001	8404702	2027-04-04	U-1741		2015-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206500-001	7049320	2028-08-19	U-1741	Drug substance, Drug product	2015-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206500-001	8470842	2029-01-18	U-1741		2015-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206500-001	8361500	2029-10-09		Drug product	2015-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206500-001	7563801	2027-04-04		Drug product	2015-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206500-001	7981905	2027-04-04	U-1741		2015-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206500-001	8178550	2027-04-04		Drug substance, Drug product	2015-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206500-001	8404702	2027-04-04	U-1741		2015-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206500-001	7049320	2028-08-19	U-1741	Drug substance, Drug product	2015-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206500-001	8470842	2029-01-18	U-1741		2015-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206500-001	8361500	2029-10-09		Drug product	2015-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206500-001	7563801	2027-04-04		Drug product	2015-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206500-001	7981905	2027-04-04	U-1741		2015-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206500-001	8178550	2027-04-04		Drug substance, Drug product	2015-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206500-001	8404702	2027-04-04	U-1741		2015-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206500-001	7049320	2028-08-19	U-1741	Drug substance, Drug product	2015-09-25	`6a471c1ec25d…`

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	N206500-001	NCE	2020-09-01	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N206500-001	NCE	2020-09-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206500-001	NCE	2020-09-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206500-001	NCE	2020-09-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206500-001	NCE	2020-09-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206500-001	NCE	2020-09-01	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ROLAPITANT HYDROCHLORIDE	90 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
57O5S1QSAQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1665503	Internal RxNorm lookup
1673373	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
8670c3cf-82d9-466d-be49-de33d8c8742b	Available on FDA.report

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
Varubi	ROLAPITANT	Luria Therapeutics LLC	8670c3cf-82d9-466d-be49-de33d8c8742b	2026-09-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206500 application number: NDA206500 ndc (package): 87628-101-02 ndc (product): 87628-101 ndc11 (package): 87628010102
Varubi	ROLAPITANT	TerSera Therapeutics LLC	a52896cd-4a98-49b8-82db-bf1985a64d97	2020-08-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206500 application number: NDA206500

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
57O5S1QSAQ	ROLAPITANT HYDROCHLORIDE	914462-92-3	ROLAPITANT HYDROCHLORIDE
NLE429IZUC	ROLAPITANT	552292-08-7	rolapitant

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87628-101-02	87628010102	2 TABLET in 1 BLISTER PACK (87628-101-02)	2 tablet	2026-09-08	No	No	Current