Home NDC 16571-245 Itraconazole
Product NDC 16571-245
11-digit product format 165710245
Labeler code 16571
Product ID 16571-245_c7336946-9638-4837-9046-1aef77694672
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Itraconazole
Dosage form CAPSULE
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA205724
Marketing category ANDA
Marketing start 2025-02-03
Substance ITRACONAZOLE
Active strength 100 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 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 A205724-001 ITRACONAZOLE ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205724-001 AB
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 · 41 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 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL 2016-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL 2016-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL 2016-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL 2016-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL 2016-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL 2016-12-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL 2016-12-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL 2016-12-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL 2016-12-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL 2016-12-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL 2016-12-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL 2016-12-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL 2016-12-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Itraconazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ITRACONAZOLE 100 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311204 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 16571-245-03 Itraconazole 30 in 1 BOTTLE CAPSULE 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-245 ITRACONAZOLE CAPSULE [RISING PHARMA HOLDINGS, INC.] 2 Current NDC, 1 package rows 20250204_6df5ff94-47ba-4881-abb4-b321e35a6955.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 16571-245-03 16571024503 30 CAPSULE in 1 BOTTLE (16571-245-03) 30 capsule 2025-02-03 No No Current