Home NDC 50419-395 NUBEQA
Product NDC 50419-395
11-digit product format 504190395
Labeler code 50419
Product ID 50419-395_fd96ab4c-d7f4-446f-93d8-1dae246a450a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name darolutamide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bayer HealthCare Pharmaceuticals Inc.
Application NDA212099
Marketing category NDA
Marketing start 2019-07-31
Substance DAROLUTAMIDE
Active strength 300 mg/1
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 1 .
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 N212099-001 NUBEQA DAROLUTAMIDE 300MG TABLET / ORAL RLD, RS 2019-07-30
Orange Book patents# Current patent rows page 1 of 1 · 17 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212099-001 10711013 2030-10-27 Drug substance, Drug product 2020-08-11 N212099-001 11046713 2030-10-27 Drug substance 2021-07-28 N212099-001 9657003 2030-10-27 U-4208 Drug substance, Drug product 2019-08-27 N212099-001 9657003 2030-10-27 U-4209 Drug substance, Drug product 2019-08-27 N212099-001 9657003 2030-10-27 U-4210 Drug substance, Drug product 2019-08-27 N212099-001 8975254 2033-03-25 U-4208 Drug substance, Drug product 2019-08-27 N212099-001 8975254 2033-03-25 U-4209 Drug substance, Drug product 2019-08-27 N212099-001 8975254 2033-03-25 U-4210 Drug substance, Drug product 2019-08-27 N212099-001 10010530 2036-01-28 Drug substance 2019-08-27 N212099-001 10383853 2036-01-28 Drug substance 2019-08-27 N212099-001 10835515 2036-01-28 U-2605 Drug product 2020-12-11 N212099-001 10835515 2036-01-28 U-4208 Drug product 2020-12-11 N212099-001 10835515 2036-01-28 U-4209 Drug product 2020-12-11 N212099-001 10835515 2036-01-28 U-4210 Drug product 2020-12-11 N212099-001 11168058 2038-02-27 Drug substance, Drug product 2022-01-27 N212099-001 12611397 2040-07-02 Drug product 2026-05-15 N212099-001 12329742 2042-06-17 Drug product 2025-07-02
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N212099-001 I-971 2028-06-03
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 2026-02-19 14:30 UTC 2026-02 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212099-001 NUBEQA 300MG TABLET / ORAL RLD, RS 2019-07-30 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 9 · 330 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 N212099-001 10711013 2030-10-27 Drug substance, Drug product 2020-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212099-001 11046713 2030-10-27 Drug substance 2021-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212099-001 9657003 2030-10-27 U-4209 Drug substance, Drug product 2019-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212099-001 9657003 2030-10-27 U-4208 Drug substance, Drug product 2019-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212099-001 9657003 2030-10-27 U-4210 Drug substance, Drug product 2019-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212099-001 8975254 2033-03-25 U-4208 Drug substance, Drug product 2019-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212099-001 8975254 2033-03-25 U-4210 Drug substance, Drug product 2019-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212099-001 8975254 2033-03-25 U-4209 Drug substance, Drug product 2019-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212099-001 10010530 2036-01-28 Drug substance 2019-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212099-001 10383853 2036-01-28 Drug substance 2019-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212099-001 10835515 2036-01-28 U-4210 Drug product 2020-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212099-001 10835515 2036-01-28 U-4208 Drug product 2020-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212099-001 10835515 2036-01-28 U-4209 Drug product 2020-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212099-001 10835515 2036-01-28 U-2605 Drug product 2020-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212099-001 11168058 2038-02-27 Drug substance, Drug product 2022-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212099-001 12329742 2042-06-17 Drug product 2025-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212099-001 10711013 2030-10-27 Drug substance, Drug product 2020-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212099-001 11046713 2030-10-27 Drug substance 2021-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212099-001 9657003 2030-10-27 U-4209 Drug substance, Drug product 2019-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212099-001 9657003 2030-10-27 U-4208 Drug substance, Drug product 2019-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212099-001 9657003 2030-10-27 U-4210 Drug substance, Drug product 2019-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212099-001 8975254 2033-03-25 U-4208 Drug substance, Drug product 2019-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212099-001 8975254 2033-03-25 U-4210 Drug substance, Drug product 2019-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212099-001 8975254 2033-03-25 U-4209 Drug substance, Drug product 2019-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212099-001 10010530 2036-01-28 Drug substance 2019-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212099-001 10383853 2036-01-28 Drug substance 2019-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212099-001 10835515 2036-01-28 U-4210 Drug product 2020-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212099-001 10835515 2036-01-28 U-4208 Drug product 2020-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212099-001 10835515 2036-01-28 U-4209 Drug product 2020-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212099-001 10835515 2036-01-28 U-2605 Drug product 2020-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212099-001 11168058 2038-02-27 Drug substance, Drug product 2022-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212099-001 12329742 2042-05-14 Drug product 2025-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212099-001 10711013 2030-10-27 Drug substance, Drug product 2020-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212099-001 11046713 2030-10-27 Drug substance 2021-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212099-001 9657003 2030-10-27 U-4209 Drug substance, Drug product 2019-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212099-001 9657003 2030-10-27 U-4208 Drug substance, Drug product 2019-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212099-001 9657003 2030-10-27 U-4210 Drug substance, Drug product 2019-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212099-001 8975254 2033-03-25 U-4208 Drug substance, Drug product 2019-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212099-001 8975254 2033-03-25 U-4210 Drug substance, Drug product 2019-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212099-001 8975254 2033-03-25 U-4209 Drug substance, Drug product 2019-08-27 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 61 observed states.
Additional Listing Data#
Finished product Yes
Brand name base NUBEQA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DAROLUTAMIDE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X05U0N2RCO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2180330 Internal RxNorm lookup 2180336 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 50419-395-01 NUBEQA 1 in 1 CARTON TABLET, FILM COATED 1 23 50419-395-01 NUBEQA 120 in 1 BOTTLE TABLET, FILM COATED 120 23 50419-395-72 NUBEQA 1 in 1 CARTON TABLET, FILM COATED 1 23 50419-395-72 NUBEQA 120 in 1 BOTTLE TABLET, FILM COATED 120 23
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50419-395 NUBEQA (DAROLUTAMIDE) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 15 Current NDC, Legacy NDC, 4 package rows 20241116_1a7cb212-56e4-4b9d-a73d-bfee7fe4735e.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NUBEQA DAROLUTAMIDE Bayer HealthCare Pharmaceuticals Inc. 1a7cb212-56e4-4b9d-a73d-bfee7fe4735e 2025-06-03 Warnings, Adverse reactions Exact identifier application applno (NDA): 212099 application number: NDA212099 ndc (product): 50419-395
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50419-395-01 50419039501 1 BOTTLE in 1 CARTON (50419-395-01) / 120 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2019-07-31 0000-00-00 No No Current 50419-395-72 50419039572 1 BOTTLE in 1 CARTON (50419-395-72) / 120 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-03-03 0000-00-00 No No Current