Home NDC 72974-120-97 Orgovyx
Product NDC 72974-120
Requested package NDC 72974-120-97
11-digit product format 729740120
Labeler code 72974
Product ID 72974-120_0d9200dd-878e-4e93-98af-e1149e84c21f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name relugolix
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sumitomo Pharma America, Inc.
Application NDA214621
Marketing category NDA
Marketing start 2020-12-18
Substance RELUGOLIX
Active strength 120 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone 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 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 N214621-001 ORGOVYX RELUGOLIX 120MG TABLET / ORAL RLD, RS 2020-12-18
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214621-001 8058280 2026-01-28 Drug substance, Drug product 2021-01-14 N214621-001 7300935 2029-01-28 Drug substance 2021-01-14 N214621-001 11795178 2033-09-27 Drug substance, Drug product 2023-10-25 N214621-001 12325714 2033-09-27 Drug substance, Drug product 2025-06-11 N214621-001 10350170 2036-02-25 Drug product 2021-01-14 N214621-001 10449191 2037-09-29 U-3020 2021-01-14 N214621-001 10786501 2037-09-29 U-3020 2021-01-14 N214621-001 11583526 2037-09-29 U-3020 2023-03-16 N214621-001 12097198 2037-09-29 U-3020 2024-09-25 N214621-001 12144809 2037-09-29 U-4035 2024-11-21 N214621-001 12336990 2037-09-29 U-3020 2025-06-25 N214621-001 12629370 2037-09-29 U-3020 2026-06-09
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 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 8 · 297 observed states.
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 N214621-001 8058280 2026-01-28 Drug substance, Drug product 2021-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 7300935 2029-01-28 Drug substance 2021-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 11795178 2033-09-27 Drug substance, Drug product 2023-10-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 12325714 2033-09-27 Drug substance, Drug product 2025-06-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 10350170 2036-02-25 Drug product 2021-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 10449191 2037-09-29 U-3020 2021-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 10786501 2037-09-29 U-3020 2021-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 11583526 2037-09-29 U-3020 2023-03-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 12097198 2037-09-29 U-3020 2024-09-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 12144809 2037-09-29 U-4035 2024-11-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 12336990 2037-09-29 U-3020 2025-06-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 12629370 2037-09-29 U-3020 2026-06-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214621-001 8058280 2026-01-28 Drug substance, Drug product 2021-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 7300935 2029-01-28 Drug substance 2021-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 11795178 2033-09-27 Drug substance, Drug product 2023-10-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 12325714 2033-09-27 Drug substance, Drug product 2025-06-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 10350170 2036-02-25 Drug product 2021-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 10449191 2037-09-29 U-3020 2021-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 10786501 2037-09-29 U-3020 2021-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 11583526 2037-09-29 U-3020 2023-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 12097198 2037-09-29 U-3020 2024-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 12144809 2037-09-29 U-4035 2024-11-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 12336990 2037-09-29 U-3020 2025-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 12629370 2037-09-29 U-3020 2026-06-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214621-001 8058280 2026-01-28 Drug substance, Drug product 2021-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 7300935 2029-01-28 Drug substance 2021-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 11795178 2033-09-27 Drug substance, Drug product 2023-10-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 12325714 2033-09-27 Drug substance, Drug product 2025-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 10350170 2036-02-25 Drug product 2021-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 10449191 2037-09-29 U-3020 2021-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 10786501 2037-09-29 U-3020 2021-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 11583526 2037-09-29 U-3020 2023-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 12097198 2037-09-29 U-3020 2024-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 12144809 2037-09-29 U-4035 2024-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 12336990 2037-09-29 U-3020 2025-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214621-001 8058280 2026-01-28 Drug substance, Drug product 2021-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214621-001 7300935 2029-01-28 Drug substance 2021-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214621-001 11795178 2033-09-27 Drug substance, Drug product 2023-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214621-001 12325714 2033-09-27 Drug substance, Drug product 2025-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214621-001 10350170 2036-02-25 Drug product 2021-01-14 31067a03dcf5…
Observed Orange Book exclusivity history# 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 Orgovyx
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RELUGOLIX 120 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination P76B05O5V6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2472783 Internal RxNorm lookup 2472789 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 72974-120-01 Orgovyx 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 12 72974-120-95 Orgovyx 16 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 16 12 72974-120-97 Orgovyx 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72974-120 ORGOVYX (RELUGOLIX) TABLET, FILM COATED [SUMITOMO PHARMA AMERICA, INC.] 11 Current NDC, Legacy NDC, 3 package rows 20241031_077a92f6-9f1b-479a-87c7-c92b5db6aa9c.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 Marketing end Sample Exclude flag Status 72974-120-97 72974012097 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-97) 2021-10-21 0000-00-00 Yes No Current