Home NDC 51862-462-08 Tolsura
Product NDC 51862-462
Requested package NDC 51862-462-08
11-digit product format 518620462
Labeler code 51862
Product ID 51862-462_2a3303f1-eee7-4c07-9532-e153be149369
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Itraconazole
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Mayne Pharma Commercial LLC
Application NDA208901
Marketing category NDA
Marketing start 2018-12-11
Substance ITRACONAZOLE
Active strength 65 mg/1
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
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 N208901-001 TOLSURA ITRACONAZOLE 65MG CAPSULE / ORAL RLD, RS 2018-12-11
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208901-001 10463740 2033-06-21 U-2453 Drug product 2019-11-27 N208901-001 10806792 2033-06-21 Drug product 2020-11-24 N208901-001 8921374 2033-06-21 Drug product 2018-12-18 N208901-001 9272046 2033-06-21 Drug product 2018-12-18 N208901-001 9713642 2033-06-21 U-2453 2018-12-18
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 · 42 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 2026-08-18 06:07:40 2026-07 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208901-001 TOLSURA 65MG CAPSULE / ORAL RLD, RS 2018-12-11 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 6 · 226 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 N208901-001 10463740 2033-06-21 U-2453 Drug product 2019-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208901-001 10806792 2033-06-21 Drug product 2020-11-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208901-001 8921374 2033-06-21 Drug product 2018-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208901-001 9272046 2033-06-21 Drug product 2018-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208901-001 9713642 2033-06-21 U-2453 2018-12-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208901-001 10463740 2033-06-21 U-2453 Drug product 2019-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208901-001 10806792 2033-06-21 Drug product 2020-11-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208901-001 8921374 2033-06-21 Drug product 2018-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208901-001 9272046 2033-06-21 Drug product 2018-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208901-001 9713642 2033-06-21 U-2453 2018-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208901-001 10463740 2033-06-21 U-2453 Drug product 2019-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208901-001 10806792 2033-06-21 Drug product 2020-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208901-001 8921374 2033-06-21 Drug product 2018-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208901-001 9272046 2033-06-21 Drug product 2018-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208901-001 9713642 2033-06-21 U-2453 2018-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208901-001 10463740 2033-06-21 U-2453 Drug product 2019-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208901-001 10806792 2033-06-21 Drug product 2020-11-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208901-001 8921374 2033-06-21 Drug product 2018-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208901-001 9272046 2033-06-21 Drug product 2018-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208901-001 9713642 2033-06-21 U-2453 2018-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208901-001 10463740 2033-06-21 U-2453 Drug product 2019-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208901-001 10806792 2033-06-21 Drug product 2020-11-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208901-001 8921374 2033-06-21 Drug product 2018-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208901-001 9272046 2033-06-21 Drug product 2018-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208901-001 9713642 2033-06-21 U-2453 2018-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208901-001 10463740 2033-06-21 U-2453 Drug product 2019-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208901-001 10806792 2033-06-21 Drug product 2020-11-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208901-001 8921374 2033-06-21 Drug product 2018-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208901-001 9272046 2033-06-21 Drug product 2018-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208901-001 9713642 2033-06-21 U-2453 2018-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208901-001 10463740 2033-06-21 U-2453 Drug product 2019-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208901-001 10806792 2033-06-21 Drug product 2020-11-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208901-001 8921374 2033-06-21 Drug product 2018-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208901-001 9272046 2033-06-21 Drug product 2018-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208901-001 9713642 2033-06-21 U-2453 2018-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208901-001 10463740 2033-06-21 U-2453 Drug product 2019-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208901-001 10806792 2033-06-21 Drug product 2020-11-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208901-001 8921374 2033-06-21 Drug product 2018-12-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208901-001 9272046 2033-06-21 Drug product 2018-12-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208901-001 9713642 2033-06-21 U-2453 2018-12-18 2680178bc6a6…
Additional Listing Data#
Finished product Yes
Brand name base Tolsura
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ITRACONAZOLE 65 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 304NUG5GF4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2106642 Internal RxNorm lookup 2106648 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 51862-462-08 Tolsura 8 in 1 BOTTLE, PLASTIC CAPSULE, GELATIN COATED 8 10 51862-462-60 Tolsura 60 in 1 BOTTLE, PLASTIC CAPSULE, GELATIN COATED 60 10 51862-462-88 Tolsura 8 in 1 BOTTLE, PLASTIC CAPSULE, GELATIN COATED 8 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51862-462 TOLSURA (ITRACONAZOLE) CAPSULE, GELATIN COATED [MAYNE PHARMA COMMERCIAL LLC] 10 Current NDC, Legacy NDC, 3 package rows 20250425_306352d1-9d5a-49ad-b72d-893b99546861.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 51862-462-08 51862046208 8 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-08) 2018-12-11 0000-00-00 No No Current