Home NDC 0002-1717-28 Inluriyo
Product NDC 0002-1717
Requested package NDC 0002-1717-28
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 Product TE source text 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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
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.
DailyMed RxNorm Mappings# 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