Home NDC 70518-3264-0 ITRACONAZOLE
Product NDC 70518-3264
Requested package NDC 70518-3264-0
11-digit product format 705183264
Labeler code 70518
Product ID 70518-3264_d07442a5-7d29-cc25-e053-2a95a90aecb5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name itraconazole
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA206741
Marketing category ANDA
Marketing start 2021-11-08
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 2022-12-31
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 · 12 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…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A206741-001 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 A206741-001 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 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
FDA-Initiated Inactive NDC Indexing# 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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70518-3264-0 70518326400 14 CAPSULE in 1 BOTTLE, PLASTIC (70518-3264-0) 14 capsule 2021-11-08 0000-00-00 No No Current