Inluriyo

Product NDC: 0002-1717
11-digit product format: 000021717
Labeler code: 0002
Product ID: 0002-1717_0f64afa6-a367-4dfe-a0ca-8631aa894f61
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: imlunestrant
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Eli Lilly and Company
Application: NDA218881
Marketing category: NDA
Marketing start: 2025-09-25
Substance: IMLUNESTRANT
Active strength: 200 mg/1
Pharmacologic classes: Breast Cancer Resistance Protein Inhibitors [MoA], Estrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], 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 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
N218881-001	INLURIYO	IMLUNESTRANT TOSYLATE	EQ 200MG BASE	TABLET / ORAL		RLD, RS	2025-09-25

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
N218881-001	10654866	2039-07-11	U-4278	Drug substance, Drug product	2025-10-16
N218881-001	11117902	2039-07-11	U-4278	Drug substance, Drug product	2025-10-16

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218881-001	NCE	2030-09-25

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.

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	N218881-001	INLURIYO	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2025-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218881-001	INLURIYO	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2025-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218881-001	INLURIYO	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2025-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218881-001	INLURIYO	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2025-09-25	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218881-001	INLURIYO	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2025-09-25	`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
2026-09-14 22:38:34	2026-08	N218881-001	10654866	2039-07-11	U-4278	Drug substance, Drug product	2025-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218881-001	11117902	2039-07-11	U-4278	Drug substance, Drug product	2025-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218881-001	10654866	2039-07-11	U-4278	Drug substance, Drug product	2025-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218881-001	11117902	2039-07-11	U-4278	Drug substance, Drug product	2025-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218881-001	10654866	2039-07-11	U-4278	Drug substance, Drug product	2025-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218881-001	11117902	2039-07-11	U-4278	Drug substance, Drug product	2025-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218881-001	10654866	2039-07-11	U-4278	Drug substance, Drug product	2025-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218881-001	11117902	2039-07-11	U-4278	Drug substance, Drug product	2025-10-16	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218881-001	10654866	2039-07-11	U-4278	Drug substance, Drug product	2025-10-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218881-001	11117902	2039-07-11	U-4278	Drug substance, Drug product	2025-10-16	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N218881-001	NCE	2030-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218881-001	NCE	2030-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218881-001	NCE	2030-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218881-001	NCE	2030-09-25	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218881-001	NCE	2030-09-25	`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: Inluriyo
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IMLUNESTRANT	200 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0002-1717-28	Inluriyo	28 in 1 BOTTLE	TABLET, FILM COATED	28	6
0002-1717-56	Inluriyo	56 in 1 BOTTLE	TABLET, FILM COATED	56	6
0002-1717-61	Inluriyo	56 in 1 BOTTLE	TABLET, FILM COATED	56	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0002-1717-28	EA - Each	0002-1717	ac6b3ee9-2937-461f-a2f7-39ec4e74e599	1	2025-10-14
0002-1717-56	EA - Each	0002-1717	f875f7b0-d5ca-4b4b-ab64-eb578468b990	1	2025-10-14

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
Inluriyo	IMLUNESTRANT	Eli Lilly and Company	5bc172e4-e8a2-441a-be52-279a7f890196	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 218881 application number: NDA218881 ndc (product): 0002-1717

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2725917	imlunestrant 200 MG Oral Tablet	PSN	5bc172e4-e8a2-441a-be52-279a7f890196	6
2725923	Inluriyo 200 MG Oral Tablet	PSN	5bc172e4-e8a2-441a-be52-279a7f890196	6
2725923	imlunestrant 200 MG Oral Tablet [Inluriyo]	SBD	5bc172e4-e8a2-441a-be52-279a7f890196	6
2725917	imlunestrant 200 MG Oral Tablet	SCD	5bc172e4-e8a2-441a-be52-279a7f890196	6
2725917	imlunestrant 200 MG (equivalent to imlunestrant tosylate 265.66 MG) Oral Tablet	SY	5bc172e4-e8a2-441a-be52-279a7f890196	6
2725923	Inluriyo 200 MG Oral Tablet	SY	5bc172e4-e8a2-441a-be52-279a7f890196	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0002-1717-28	00002171728	28 TABLET, FILM COATED in 1 BOTTLE (0002-1717-28)	2025-10-16	No	No	Current
0002-1717-56	00002171756	56 TABLET, FILM COATED in 1 BOTTLE (0002-1717-56)	2025-10-15	No	No	Current
0002-1717-61	00002171761	56 TABLET, FILM COATED in 1 BOTTLE (0002-1717-61)	2025-11-13	Yes	No	Current