Home NDC 49884-239 Itraconazole
Product NDC 49884-239
11-digit product format 498840239
Labeler code 49884
Product ID 49884-239_a72890ec-d1bc-474d-ba59-e8efb7de6eac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Itraconazole
Dosage form CAPSULE
Route ORAL
Labeler Par Pharmaceutical, Inc.
Application ANDA205724
Marketing category ANDA
Marketing start 2016-07-01
Marketing end 0000-00-00
Substance ITRACONAZOLE
Active strength 100 mg/1
Pharmacologic classes Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49884-239-11 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49884-239-11 f5e01cc5f278…a2eaf40c39c3…
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 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 · 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 A205724-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 caaa826d4ba7…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…
Observed Orange Book normalized TE history# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-239 ITRACONAZOLE CAPSULE [PAR PHARMACEUTICAL, INC.] 11 Legacy NDC 20230913_8d34a00f-f6f9-4bd5-9cba-505038d15c46.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 Itraconazole ITRACONAZOLE Rising Pharma Holdings, Inc. 6df5ff94-47ba-4881-abb4-b321e35a6955 2025-01-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205724 application number: ANDA205724
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49884-239-11 49884023911 30 CAPSULE in 1 BOTTLE (49884-239-11) 30 capsule 2016-07-01 0000-00-00 No No Current