Home NDC 72187-0101 ORSERDU
Product NDC 72187-0101
11-digit product format 721870101
Labeler code 72187
Product ID 72187-0101_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 86 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.
Additional Listing Data#
Finished product Yes
Brand name base ORSERDU
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ELACESTRANT 86 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 72187-0101-3 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 72187-0101 ORSERDU (ELACESTRANT) TABLET, FILM COATED [STEMLINE THERAPEUTICS, INC.] 5 Current NDC, 1 package rows 20240805_aa66ae5c-2bd2-4444-8178-b55651e054ef.zip
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 72187-0101-3 72187010103 30 TABLET, FILM COATED in 1 BOTTLE (72187-0101-3) 2023-01-27 No No Current