Home NDC 59676-604 ERLEADA
Product NDC 59676-604
11-digit product format 596760604
Labeler code 59676
Product ID 59676-604_8d917bea-59a6-4338-b818-6ad5c62d02f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Apalutamide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Janssen Products, LP
Application NDA210951
Marketing category NDA
Marketing start 2018-02-14
Substance APALUTAMIDE
Active strength 240 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210951-001 ERLEADA APALUTAMIDE 60MG TABLET / ORAL AB RLD 2018-02-14 N210951-002 ERLEADA APALUTAMIDE 240MG TABLET / ORAL RLD, RS 2023-02-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N210951-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 36 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210951-001 8802689 2027-03-27 U-2237 2018-03-05 N210951-001 8802689 2027-03-27 U-2624 2018-03-05 N210951-001 9388159 2027-03-27 Drug substance, Drug product 2018-03-05 N210951-001 9987261 2027-03-27 Drug product 2018-10-18 N210951-001 8445507 2032-02-14 U-2237 Drug substance, Drug product 2018-03-05 N210951-001 8445507 2032-02-14 U-2624 Drug substance, Drug product 2018-03-05 N210951-001 9481663 2033-06-04 U-2237 Drug substance, Drug product 2018-03-05 N210951-001 9481663 2033-06-04 U-2624 Drug substance, Drug product 2018-03-05 N210951-001 10849888 2033-09-23 U-3013 2021-01-05 N210951-001 9884054 2033-09-23 U-2237 2018-03-05 N210951-001 RE49353 2033-09-23 U-2381 2023-01-12 N210951-001 RE50642 2033-09-23 U-4450 2026-04-02 N210951-001 12303493 2035-12-03 Drug product 2025-06-16 N210951-001 10702508 2038-04-30 U-3012 2021-01-05 N210951-001 11963952 2040-01-30 U-3901 2024-04-26 N210951-001 12303497 2040-01-30 U-4448 2025-06-16 N210951-001 12303497 2040-01-30 U-4494 2025-06-16 N210951-001 11723898 2041-01-14 U-4449 2026-04-02 N210951-002 8802689 2027-03-27 U-2237 2023-02-27 N210951-002 8802689 2027-03-27 U-2624 2023-02-27 N210951-002 9388159 2027-03-27 Drug substance, Drug product 2023-02-27 N210951-002 9987261 2027-03-27 Drug product 2023-02-27 N210951-002 8445507 2032-02-14 U-2237 Drug substance, Drug product 2023-02-27 N210951-002 8445507 2032-02-14 U-2624 Drug substance, Drug product 2023-02-27 N210951-002 9481663 2033-06-04 U-2237 Drug substance, Drug product 2023-02-27 N210951-002 9481663 2033-06-04 U-2624 Drug substance, Drug product 2023-02-27 N210951-002 10849888 2033-09-23 U-3013 2023-02-27 N210951-002 9884054 2033-09-23 U-2237 2023-02-27 N210951-002 RE49353 2033-09-23 U-2381 2023-02-27 N210951-002 RE50642 2033-09-23 U-4450 2026-04-02 N210951-002 12303493 2035-12-03 Drug product 2025-06-16 N210951-002 10702508 2038-04-30 U-3012 2023-02-27 N210951-002 11963952 2040-01-30 U-3901 2024-04-26 N210951-002 12303497 2040-01-30 U-4448 2025-06-16 N210951-002 12303497 2040-01-30 U-4494 2025-06-16 N210951-002 11723898 2041-01-14 U-4449 2026-04-02
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 · 64 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 N210951-001 ERLEADA 60MG TABLET / ORAL AB RLD 2018-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-002 ERLEADA 240MG TABLET / ORAL RLD, RS 2023-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210951-001 ERLEADA 60MG TABLET / ORAL AB RLD 2018-02-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210951-002 ERLEADA 240MG TABLET / ORAL RLD, RS 2023-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210951-001 ERLEADA 60MG TABLET / ORAL AB RLD 2018-02-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210951-002 ERLEADA 240MG TABLET / ORAL RLD, RS 2023-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210951-001 ERLEADA 60MG TABLET / ORAL RLD 2018-02-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210951-002 ERLEADA 240MG TABLET / ORAL RLD, RS 2023-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210951-001 ERLEADA 60MG TABLET / ORAL RLD 2018-02-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210951-002 ERLEADA 240MG TABLET / ORAL RLD, RS 2023-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210951-001 ERLEADA 60MG TABLET / ORAL RLD 2018-02-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210951-002 ERLEADA 240MG TABLET / ORAL RLD, RS 2023-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210951-001 ERLEADA 60MG TABLET / ORAL RLD 2018-02-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210951-002 ERLEADA 240MG TABLET / ORAL RLD, RS 2023-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210951-001 ERLEADA 60MG TABLET / ORAL RLD 2018-02-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210951-002 ERLEADA 240MG TABLET / ORAL RLD, RS 2023-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210951-001 ERLEADA 60MG TABLET / ORAL RLD 2018-02-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210951-002 ERLEADA 240MG TABLET / ORAL RLD, RS 2023-02-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210951-001 ERLEADA 60MG TABLET / ORAL RLD 2018-02-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210951-002 ERLEADA 240MG TABLET / ORAL RLD, RS 2023-02-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210951-001 ERLEADA 60MG TABLET / ORAL RLD 2018-02-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210951-002 ERLEADA 240MG TABLET / ORAL RLD, RS 2023-02-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210951-001 ERLEADA 60MG TABLET / ORAL RLD 2018-02-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210951-002 ERLEADA 240MG TABLET / ORAL RLD, RS 2023-02-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210951-001 ERLEADA 60MG TABLET / ORAL RLD 2018-02-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210951-002 ERLEADA 240MG TABLET / ORAL RLD, RS 2023-02-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210951-001 ERLEADA 60MG TABLET / ORAL RLD 2018-02-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N210951-002 ERLEADA 240MG TABLET / ORAL RLD, RS 2023-02-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210951-001 ERLEADA 60MG TABLET / ORAL RLD, RS 2018-02-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210951-001 ERLEADA 60MG TABLET / ORAL RLD, RS 2018-02-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210951-001 ERLEADA 60MG TABLET / ORAL RLD, RS 2018-02-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210951-001 ERLEADA 60MG TABLET / ORAL RLD, RS 2018-02-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210951-001 ERLEADA 60MG TABLET / ORAL RLD, RS 2018-02-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210951-001 ERLEADA 60MG TABLET / ORAL RLD, RS 2018-02-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210951-001 ERLEADA 60MG TABLET / ORAL RLD, RS 2018-02-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210951-001 ERLEADA 60MG TABLET / ORAL RLD, RS 2018-02-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210951-001 ERLEADA 60MG TABLET / ORAL RLD, RS 2018-02-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210951-001 ERLEADA 60MG TABLET / ORAL RLD, RS 2018-02-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210951-001 ERLEADA 60MG TABLET / ORAL RLD, RS 2018-02-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210951-001 ERLEADA 60MG TABLET / ORAL RLD, RS 2018-02-14 b00525d2431f…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210951-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210951-001 AB 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210951-001 AB 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210951-001 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 22 · 856 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 N210951-001 8802689 2027-03-27 U-2237 2018-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-001 8802689 2027-03-27 U-2624 2018-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-001 9388159 2027-03-27 Drug substance, Drug product 2018-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-001 9987261 2027-03-27 Drug product 2018-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-001 8445507 2030-09-15 U-2624 Drug substance, Drug product 2018-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-001 8445507 2030-09-15 U-2237 Drug substance, Drug product 2018-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-001 9481663 2033-06-04 U-2624 Drug substance, Drug product 2018-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-001 9481663 2033-06-04 U-2237 Drug substance, Drug product 2018-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-001 10849888 2033-09-23 U-3013 2021-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-001 9884054 2033-09-23 U-2237 2018-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-001 RE49353 2033-09-23 U-2381 2023-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-001 12303493 2035-12-03 Drug product 2025-06-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-001 10702508 2038-04-30 U-3012 2021-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-001 11963952 2040-01-30 U-3901 2024-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-001 12303497 2040-01-30 U-4201 2025-06-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-001 12303497 2040-01-30 U-4202 2025-06-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-002 8802689 2027-03-27 U-2237 2023-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-002 8802689 2027-03-27 U-2624 2023-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-002 9388159 2027-03-27 Drug substance, Drug product 2023-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-002 9987261 2027-03-27 Drug product 2023-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-002 8445507 2030-09-15 U-2237 Drug substance, Drug product 2023-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-002 8445507 2030-09-15 U-2624 Drug substance, Drug product 2023-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-002 9481663 2033-06-04 U-2624 Drug substance, Drug product 2023-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-002 9481663 2033-06-04 U-2237 Drug substance, Drug product 2023-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-002 10849888 2033-09-23 U-3013 2023-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-002 9884054 2033-09-23 U-2237 2023-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-002 RE49353 2033-09-23 U-2381 2023-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-002 12303493 2035-12-03 Drug product 2025-06-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-002 10702508 2038-04-30 U-3012 2023-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-002 11963952 2040-01-30 U-3901 2024-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-002 12303497 2040-01-30 U-4201 2025-06-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210951-002 12303497 2040-01-30 U-4202 2025-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210951-001 8802689 2027-03-27 U-2237 2018-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210951-001 8802689 2027-03-27 U-2624 2018-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210951-001 9388159 2027-03-27 Drug substance, Drug product 2018-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210951-001 9987261 2027-03-27 Drug product 2018-10-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210951-001 8445507 2030-09-15 U-2624 Drug substance, Drug product 2018-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210951-001 8445507 2030-09-15 U-2237 Drug substance, Drug product 2018-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210951-001 9481663 2033-06-04 U-2624 Drug substance, Drug product 2018-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210951-001 9481663 2033-06-04 U-2237 Drug substance, Drug product 2018-03-05 31067a03dcf5…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base ERLEADA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength APALUTAMIDE 240 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4T36H88UA7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1999581 Internal RxNorm lookup 1999587 Internal RxNorm lookup 2630215 Internal RxNorm lookup 2630217 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 59676-604-14 ERLEADA 1 in 1 CARTON TABLET, FILM COATED 1 28 59676-604-14 ERLEADA 14 in 1 BLISTER PACK TABLET, FILM COATED 14 28 59676-604-30 ERLEADA 30 in 1 BOTTLE TABLET, FILM COATED 30 28
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59676-604 ERLEADA (APALUTAMIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP] 26 Current NDC, 3 package rows 20250406_d1cda4f7-cb33-46ea-b9ac-431f6452b1a5.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 Units Marketing start Sample Exclude flag Status 59676-604-14 59676060414 1 BLISTER PACK in 1 CARTON (59676-604-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2023-02-17 Yes No Current 59676-604-30 59676060430 30 TABLET, FILM COATED in 1 BOTTLE (59676-604-30) 2023-02-17 No No Current