Home NDC 72065-003 Recorlev
Product NDC 72065-003
11-digit product format 720650003
Labeler code 72065
Product ID 72065-003_ed08de98-fda5-455e-94b3-79ebf1c046cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levoketoconazole
Dosage form TABLET
Route ORAL
Labeler Xeris Pharmaceuticals, Inc.
Application NDA214133
Marketing category NDA
Marketing start 2021-12-30
Substance LEVOKETOCONAZOLE
Active strength 150 mg/1
Pharmacologic classes Cortisol Synthesis Inhibitor [EPC], Cytochrome P450 11A1 Inhibitors [MoA], Cytochrome P450 11B1 Inhibitors [MoA], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
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 42 .
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 N214133-001 RECORLEV LEVOKETOCONAZOLE 150MG TABLET / ORAL RLD, RS 2021-12-30
Orange Book patents# Current patent rows page 1 of 1 · 9 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214133-001 10098877 2026-01-10 U-3283 2022-01-27 N214133-001 10517868 2026-01-10 U-3283 2022-01-27 N214133-001 10835530 2026-01-10 U-3283 2022-01-27 N214133-001 11478471 2026-01-10 U-3283 2022-10-31 N214133-001 9918984 2028-05-03 U-3283 2022-01-27 N214133-001 11020393 2040-03-02 U-3282 2022-01-27 N214133-001 11278547 2040-03-02 U-3282 2022-03-24 N214133-001 11903940 2040-03-02 U-3821 2024-03-08 N214133-001 12377096 2040-03-02 U-4236 2025-08-12
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214133-001 NCE* 2026-12-30 N214133-001 ODE-385 2028-12-30
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 2026-08-18 06:07:40 2026-07 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214133-001 RECORLEV 150MG TABLET / ORAL RLD, RS 2021-12-30 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 7 · 242 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N214133-001 10098877 2026-01-10 U-3283 2022-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214133-001 10517868 2026-01-10 U-3283 2022-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214133-001 10835530 2026-01-10 U-3283 2022-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214133-001 11478471 2026-01-10 U-3283 2022-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214133-001 9918984 2028-05-03 U-3283 2022-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214133-001 11020393 2040-03-02 U-3282 2022-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214133-001 11278547 2040-03-02 U-3282 2022-03-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214133-001 11903940 2040-03-02 U-3821 2024-03-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214133-001 12377096 2040-03-02 U-4236 2025-08-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214133-001 10098877 2026-01-10 U-3283 2022-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214133-001 10517868 2026-01-10 U-3283 2022-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214133-001 10835530 2026-01-10 U-3283 2022-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214133-001 11478471 2026-01-10 U-3283 2022-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214133-001 9918984 2028-05-03 U-3283 2022-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214133-001 11020393 2040-03-02 U-3282 2022-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214133-001 11278547 2040-03-02 U-3282 2022-03-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214133-001 11903940 2040-03-02 U-3821 2024-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214133-001 12377096 2040-03-02 U-4236 2025-08-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214133-001 10098877 2026-01-10 U-3283 2022-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214133-001 10517868 2026-01-10 U-3283 2022-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214133-001 10835530 2026-01-10 U-3283 2022-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214133-001 11478471 2026-01-10 U-3283 2022-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214133-001 9918984 2028-05-03 U-3283 2022-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214133-001 11020393 2040-03-02 U-3282 2022-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214133-001 11278547 2040-03-02 U-3282 2022-03-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214133-001 11903940 2040-03-02 U-3821 2024-03-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214133-001 12377096 2040-03-02 U-4236 2025-08-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214133-001 10098877 2026-01-10 U-3283 2022-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214133-001 10517868 2026-01-10 U-3283 2022-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214133-001 10835530 2026-01-10 U-3283 2022-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214133-001 11478471 2026-01-10 U-3283 2022-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214133-001 9918984 2028-05-03 U-3283 2022-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214133-001 11020393 2040-03-02 U-3282 2022-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214133-001 11278547 2040-03-02 U-3282 2022-03-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214133-001 11903940 2040-03-02 U-3821 2024-03-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214133-001 10098877 2026-01-10 U-3283 2022-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214133-001 10517868 2026-01-10 U-3283 2022-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214133-001 10835530 2026-01-10 U-3283 2022-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214133-001 11478471 2026-01-10 U-3283 2022-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214133-001 9918984 2026-01-10 U-3283 2022-01-27 fd3edfee7708…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Recorlev
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOKETOCONAZOLE 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2DJ8R0NT7K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2588848 Internal RxNorm lookup 2588854 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72065-003-01 Recorlev 50 in 1 BOTTLE TABLET 50 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72065-003 RECORLEV (LEVOKETOCONAZOLE) TABLET [XERIS PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20241205_d4c5fead-bc4a-fb02-e053-2a95a90ae4fc.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 Recorlev LEVOKETOCONAZOLE Xeris Pharmaceuticals, Inc. d4c5fead-bc4a-fb02-e053-2a95a90ae4fc 2026-03-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 214133 application number: NDA214133 ndc (product): 72065-003
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 72065-003-01 72065000301 50 TABLET in 1 BOTTLE (72065-003-01) 50 tablet 2021-12-30 0000-00-00 No No Current