Brinsupri

Product NDC: 71558-001
Requested package NDC: 71558-001-30
11-digit product format: 715580001
Labeler code: 71558
Product ID: 71558-001_43046e5b-e40b-423d-a98d-a2fecc2cbd2e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Brensocatib
Dosage form: TABLET
Route: ORAL
Labeler: Insmed Incorporated
Application: NDA217673
Marketing category: NDA
Marketing start: 2025-08-12
Substance: BRENSOCATIB
Active strength: 10 mg/1
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217673-001	BRINSUPRI	BRENSOCATIB	10MG	TABLET / ORAL		RLD	2025-08-12
N217673-002	BRINSUPRI	BRENSOCATIB	25MG	TABLET / ORAL		RLD, RS	2025-08-12

Orange Book patents#

Current patent rows page 1 of 1 · 28 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217673-001	10287258	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-001	10669245	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-001	11655221	2035-01-21	U-4257	Drug product	2025-09-05
N217673-001	11655222	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-001	11655223	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-001	11655224	2035-01-21	U-4257	Drug product	2025-09-05
N217673-001	11673871	2035-01-21	U-4257	Drug product	2025-09-05
N217673-001	11773069	2035-01-21	U-4257	Drug product	2025-09-05
N217673-001	11814359	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-001	12054465	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-001	9815805	2035-01-21	U-4257		2025-09-05
N217673-001	9522894	2035-03-12		Drug substance	2025-09-05
N217673-001	12201638	2039-03-01		Drug product	2025-09-05
N217673-001	12059424	2040-02-21		Drug product	2025-09-05
N217673-002	10287258	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-002	10669245	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-002	11655221	2035-01-21	U-4257	Drug product	2025-09-05
N217673-002	11655222	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-002	11655223	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-002	11655224	2035-01-21	U-4257	Drug product	2025-09-05
N217673-002	11673871	2035-01-21	U-4257	Drug product	2025-09-05
N217673-002	11773069	2035-01-21	U-4257	Drug product	2025-09-05
N217673-002	11814359	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-002	12054465	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-002	9815805	2035-01-21	U-4257		2025-09-05
N217673-002	9522894	2035-03-12		Drug substance	2025-09-05
N217673-002	12201638	2039-03-01		Drug product	2025-09-05
N217673-002	12059424	2040-02-21		Drug product	2025-09-05

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217673-001	NCE	2030-08-12
N217673-002	NCE	2030-08-12

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	N217673-001	BRINSUPRI	10MG	TABLET / ORAL	RLD	2025-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	BRINSUPRI	25MG	TABLET / ORAL	RLD, RS	2025-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	BRINSUPRI	10MG	TABLET / ORAL	RLD	2025-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-002	BRINSUPRI	25MG	TABLET / ORAL	RLD, RS	2025-08-12	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217673-001	BRINSUPRI	10MG	TABLET / ORAL	RLD	2025-08-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217673-002	BRINSUPRI	25MG	TABLET / ORAL	RLD, RS	2025-08-12	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217673-001	10287258	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	10669245	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	11655221	2035-01-21	U-4257	Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	11655222	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	11655223	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	11655224	2035-01-21	U-4257	Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	11673871	2035-01-21	U-4257	Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	11773069	2035-01-21	U-4257	Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	11814359	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	12054465	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	9815805	2035-01-21	U-4257		2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	9522894	2035-03-12		Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	12201638	2039-03-01		Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	12059424	2040-02-21		Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	10287258	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	10669245	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	11655221	2035-01-21	U-4257	Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	11655222	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	11655223	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	11655224	2035-01-21	U-4257	Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	11673871	2035-01-21	U-4257	Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	11773069	2035-01-21	U-4257	Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	11814359	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	12054465	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	9815805	2035-01-21	U-4257		2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	9522894	2035-03-12		Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	12201638	2039-03-01		Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	12059424	2040-02-21		Drug product	2025-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	10287258	2035-01-21	U-4257	Drug substance	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	10669245	2035-01-21	U-4257	Drug substance	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	11655221	2035-01-21	U-4257	Drug product	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	11655222	2035-01-21	U-4257	Drug substance	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	11655223	2035-01-21	U-4257	Drug substance	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	11655224	2035-01-21	U-4257	Drug product	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	11673871	2035-01-21	U-4257	Drug product	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	11773069	2035-01-21	U-4257	Drug product	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	11814359	2035-01-21	U-4257	Drug substance	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	12054465	2035-01-21	U-4257	Drug substance	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	9815805	2035-01-21	U-4257		2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	9522894	2035-03-12		Drug substance	2025-09-05	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217673-001	NCE	2030-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	NCE	2030-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	NCE	2030-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-002	NCE	2030-08-12	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217673-001	NCE	2030-08-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217673-002	NCE	2030-08-12	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BRENSOCATIB	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
25CG88L0BB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2721885	Internal RxNorm lookup
2721891	Internal RxNorm lookup
2721893	Internal RxNorm lookup
2721895	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
b56986ae-e7db-421e-b622-a7f41e321f3d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71558-001-30	Brinsupri	30 in 1 BOTTLE	TABLET	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71558-001-30	EA - Each	71558-001	fb164064-51bb-46f1-9759-b5f4e272b284	1	2025-09-12

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
Brinsupri	BRENSOCATIB	Insmed Incorporated	b56986ae-e7db-421e-b622-a7f41e321f3d	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217673 application number: NDA217673 ndc (package): 71558-001-30 ndc (product): 71558-001 ndc11 (package): 71558000130

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2721885	brensocatib 10 MG Oral Tablet	PSN	b56986ae-e7db-421e-b622-a7f41e321f3d	3
2721893	brensocatib 25 MG Oral Tablet	PSN	b56986ae-e7db-421e-b622-a7f41e321f3d	3
2721891	Brinsupri 10 MG Oral Tablet	PSN	b56986ae-e7db-421e-b622-a7f41e321f3d	3
2721895	Brinsupri 25 MG Oral Tablet	PSN	b56986ae-e7db-421e-b622-a7f41e321f3d	3
2721891	brensocatib 10 MG Oral Tablet [Brinsupri]	SBD	b56986ae-e7db-421e-b622-a7f41e321f3d	3
2721895	brensocatib 25 MG Oral Tablet [Brinsupri]	SBD	b56986ae-e7db-421e-b622-a7f41e321f3d	3
2721885	brensocatib 10 MG Oral Tablet	SCD	b56986ae-e7db-421e-b622-a7f41e321f3d	3
2721893	brensocatib 25 MG Oral Tablet	SCD	b56986ae-e7db-421e-b622-a7f41e321f3d	3
2721891	Brinsupri 10 MG Oral Tablet	SY	b56986ae-e7db-421e-b622-a7f41e321f3d	3
2721895	Brinsupri 25 MG Oral Tablet	SY	b56986ae-e7db-421e-b622-a7f41e321f3d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71558-001-30	71558000130	30 TABLET in 1 BOTTLE (71558-001-30)	30 tablet	2025-08-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Brinsupri	Insmed Incorporated \| Patheon Inc. \| Esteve Huayi Pharmaceutical Co., Ltd. \| Esteve Quimica, SA	2026-03-16	HUMAN PRESCRIPTION DRUG LABEL	3