RHAPSIDO

Product NDC: 0078-1483
Requested package NDC: 0078-1483-93
11-digit product format: 000781483
Labeler code: 0078
Product ID: 0078-1483_03fb4b82-836d-4847-a9b5-e5695da55c1c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: remibrutinib
Dosage form: TABLET
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA218436
Marketing category: NDA
Marketing start: 2025-09-30
Substance: REMIBRUTINIB
Active strength: 25 mg/1
Pharmacologic classes: Bruton's Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein 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 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
N218436-001	RHAPSIDO	REMIBRUTINIB	25MG	TABLET / ORAL		RLD, RS	2025-09-30

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218436-001	10457647	2034-11-13	U-4280		2025-10-21
N218436-001	9512084	2034-11-13		Drug substance, Drug product	2025-10-21
N218436-001	12419889	2043-01-19	U-4281		2025-10-21

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218436-001	NCE	2030-09-30

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
2026-10-15 13:18:30	2026-09	N218436-001	RHAPSIDO	25MG	TABLET / ORAL	RLD, RS	2025-09-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N218436-001	RHAPSIDO	25MG	TABLET / ORAL	RLD, RS	2025-09-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218436-001	RHAPSIDO	25MG	TABLET / ORAL	RLD, RS	2025-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218436-001	RHAPSIDO	25MG	TABLET / ORAL	RLD, RS	2025-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218436-001	RHAPSIDO	25MG	TABLET / ORAL	RLD, RS	2025-09-30	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218436-001	RHAPSIDO	25MG	TABLET / ORAL	RLD, RS	2025-09-30	`a50c72e98297…`

Observed Orange Book patent history#

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	N218436-001	10457647	2034-11-13	U-4280		2025-10-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218436-001	9512084	2034-11-13		Drug substance, Drug product	2025-10-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218436-001	12419889	2043-01-19	U-4281		2025-10-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N218436-001	10457647	2034-11-13	U-4280		2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218436-001	9512084	2034-11-13		Drug substance, Drug product	2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218436-001	12419889	2043-01-19	U-4281		2025-10-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218436-001	10457647	2034-11-13	U-4280		2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218436-001	9512084	2034-11-13		Drug substance, Drug product	2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218436-001	12419889	2043-01-19	U-4281		2025-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218436-001	10457647	2034-11-13	U-4280		2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218436-001	9512084	2034-11-13		Drug substance, Drug product	2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218436-001	12419889	2043-01-20	U-4281		2025-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218436-001	10457647	2034-11-13	U-4280		2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218436-001	9512084	2034-11-13		Drug substance, Drug product	2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218436-001	12419889	2043-01-20	U-4281		2025-10-21	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218436-001	10457647	2034-11-13	U-4280		2025-10-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218436-001	9512084	2034-11-13		Drug substance, Drug product	2025-10-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218436-001	12419889	2043-01-19	U-4281		2025-10-21	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N218436-001	NCE	2030-09-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N218436-001	NCE	2030-09-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218436-001	NCE	2030-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218436-001	NCE	2030-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218436-001	NCE	2030-09-30	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218436-001	NCE	2030-09-30	`a50c72e98297…`

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: RHAPSIDO
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
REMIBRUTINIB	25 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0078-1483-20	RHAPSIDO	60 in 1 BOTTLE	TABLET	60	2
0078-1483-92	RHAPSIDO	30 in 1 BOTTLE	TABLET	30	2
0078-1483-92	RHAPSIDO	2 in 1 CARTON	TABLET	2	2
0078-1483-93	RHAPSIDO	30 in 1 BOTTLE	TABLET	30	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-1483-20	EA - Each	0078-1483	16d7ab04-bb1c-43cb-95ee-50d7a266620a	1	2025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2724392	remibrutinib 25 MG Oral Tablet	PSN	e5e89bff-6ced-4165-acc5-fb13136b3a3d	2
2724398	Rhapsido 25 MG Oral Tablet	PSN	e5e89bff-6ced-4165-acc5-fb13136b3a3d	2
2724398	remibrutinib 25 MG Oral Tablet [Rhapsido]	SBD	e5e89bff-6ced-4165-acc5-fb13136b3a3d	2
2724392	remibrutinib 25 MG Oral Tablet	SCD	e5e89bff-6ced-4165-acc5-fb13136b3a3d	2
2724398	Rhapsido 25 MG Oral Tablet	SY	e5e89bff-6ced-4165-acc5-fb13136b3a3d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0078-1483-93	00078148393	30 TABLET in 1 BOTTLE (0078-1483-93)	30 tablet	2026-03-23	Yes	No	Current