Home NDC 72187-0102 ORSERDU
Product NDC 72187-0102
11-digit product format 721870102
Labeler code 72187
Product ID 72187-0102_42ec5c9c-8984-4561-a4eb-c6ddc916c18a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Elacestrant
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Stemline Therapeutics, Inc.
Application NDA217639
Marketing category NDA
Marketing start 2023-01-27
Substance ELACESTRANT
Active strength 345 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 2026-12-31
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 N217639-001 ORSERDU ELACESTRANT HYDROCHLORIDE EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 N217639-002 ORSERDU ELACESTRANT HYDROCHLORIDE EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217639-001 7612114 2026-08-18 U-3523 Drug substance, Drug product 2023-03-10 N217639-001 10071066 2034-10-10 U-3524 2023-02-24 N217639-001 11779552 2034-10-10 U-3524 2023-11-06 N217639-001 10420734 2036-10-03 U-3524 2023-03-10 N217639-001 11819480 2037-02-28 U-3523 2023-12-21 N217639-001 10385008 2038-01-05 Drug substance, Drug product 2023-03-10 N217639-001 10745343 2038-01-05 U-3523 2023-02-24 N217639-002 7612114 2026-08-18 U-3523 Drug substance, Drug product 2023-03-10 N217639-002 10071066 2034-10-10 U-3524 2023-02-24 N217639-002 11779552 2034-10-10 U-3524 2023-11-06 N217639-002 10420734 2036-10-03 U-3524 2023-03-10 N217639-002 11819480 2037-02-28 U-3523 2023-12-21 N217639-002 10385008 2038-01-05 Drug substance, Drug product 2023-03-10 N217639-002 10745343 2038-01-05 U-3523 2023-02-24
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217639-001 NCE 2028-01-27 N217639-002 NCE 2028-01-27
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 · 46 observed 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 2026-02-19 14:30 UTC 2026-02 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217639-001 ORSERDU EQ 86MG BASE TABLET / ORAL RLD 2023-01-27 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217639-002 ORSERDU EQ 345MG BASE TABLET / ORAL RLD, RS 2023-01-27 a67488948f0b…
Observed Orange Book patent history# Patent history page 1 of 9 · 344 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 N217639-001 7612114 2026-08-18 U-3523 Drug substance, Drug product 2023-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217639-001 10071066 2034-10-10 U-3524 2023-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217639-001 11779552 2034-10-10 U-3524 2023-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217639-001 10420734 2036-10-03 U-3524 2023-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217639-001 11819480 2037-02-28 U-3523 2023-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217639-001 10385008 2038-01-05 Drug substance, Drug product 2023-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217639-001 10745343 2038-01-05 U-3523 2023-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217639-002 7612114 2026-08-18 U-3523 Drug substance, Drug product 2023-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217639-002 10071066 2034-10-10 U-3524 2023-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217639-002 11779552 2034-10-10 U-3524 2023-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217639-002 10420734 2036-10-03 U-3524 2023-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217639-002 11819480 2037-02-28 U-3523 2023-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217639-002 10385008 2038-01-05 Drug substance, Drug product 2023-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217639-002 10745343 2038-01-05 U-3523 2023-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217639-001 8399520 2025-12-25 U-3523 Drug substance, Drug product 2023-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217639-001 7612114 2026-08-18 U-3523 Drug substance, Drug product 2023-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217639-001 10071066 2034-10-10 U-3524 2023-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217639-001 11779552 2034-10-10 U-3524 2023-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217639-001 10420734 2036-10-03 U-3524 2023-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217639-001 11819480 2037-02-28 U-3523 2023-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217639-001 10385008 2038-01-05 Drug substance, Drug product 2023-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217639-001 10745343 2038-01-05 U-3523 2023-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217639-002 8399520 2025-12-25 U-3523 Drug substance, Drug product 2023-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217639-002 7612114 2026-08-18 U-3523 Drug substance, Drug product 2023-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217639-002 10071066 2034-10-10 U-3524 2023-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217639-002 11779552 2034-10-10 U-3524 2023-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217639-002 10420734 2036-10-03 U-3524 2023-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217639-002 11819480 2037-02-28 U-3523 2023-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217639-002 10385008 2038-01-05 Drug substance, Drug product 2023-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217639-002 10745343 2038-01-05 U-3523 2023-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217639-001 8399520 2025-12-25 U-3523 Drug substance, Drug product 2023-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217639-001 7612114 2026-08-18 U-3523 Drug substance, Drug product 2023-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217639-001 10071066 2034-10-10 U-3524 2023-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217639-001 10420734 2034-10-10 U-3524 2023-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217639-001 11779552 2034-10-10 U-3524 2023-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217639-001 11819480 2037-02-28 U-3523 2023-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217639-001 10385008 2038-01-05 Drug substance, Drug product 2023-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217639-001 10745343 2038-01-05 U-3523 2023-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217639-002 8399520 2025-12-25 U-3523 Drug substance, Drug product 2023-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217639-002 7612114 2026-08-18 U-3523 Drug substance, Drug product 2023-03-10 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 46 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base ORSERDU
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ELACESTRANT 345 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FM6A2627A8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2628478 Internal RxNorm lookup 2628484 Internal RxNorm lookup 2628487 Internal RxNorm lookup 2628489 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72187-0102-3 ORSERDU 30 in 1 BOTTLE TABLET, FILM COATED 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72187-0102 ORSERDU (ELACESTRANT) TABLET, FILM COATED [STEMLINE THERAPEUTICS, INC.] 5 Current NDC, 1 package rows 20240805_aa66ae5c-2bd2-4444-8178-b55651e054ef.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72187-0102-3 72187010203 30 TABLET, FILM COATED in 1 BOTTLE (72187-0102-3) 2023-01-27 No No Current