Home NDC 10147-1700 itraconazole
Product NDC 10147-1700
11-digit product format 101471700
Labeler code 10147
Product ID 10147-1700_2cca3625-96e8-34cf-e063-6294a90ac975
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ITRACONAZOLE
Dosage form CAPSULE
Route ORAL
Labeler Patriot Pharmaceuticals
Application NDA020083
Marketing category NDA
Marketing start 2005-02-01
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 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 N020083-001 SPORANOX ITRACONAZOLE 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020083-001 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 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020083-001 SPORANOX 100MG CAPSULE / ORAL AB RLD, RS 1992-09-11 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 10147-1700-3 itraconazole 30 in 1 BOTTLE CAPSULE 30 28 10147-1700-7 itraconazole 7 in 1 DOSE PACK CAPSULE 7 28 10147-1700-7 itraconazole 1 in 1 POUCH CAPSULE 1 28
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10147-1700 ITRACONAZOLE CAPSULE [PATRIOT PHARMACEUTICALS] 28 Current NDC, Legacy NDC, 3 package rows 20250130_6242b7ad-eaa0-a524-b6e0-ec33e63407db.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 · 2 matching rows.
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 10147-1700-3 10147170003 30 CAPSULE in 1 BOTTLE (10147-1700-3) 30 capsule 2005-02-01 0000-00-00 No No Current 10147-1700-7 10147170007 7 POUCH in 1 DOSE PACK (10147-1700-7) > 1 BLISTER PACK in 1 POUCH > 4 CAPSULE in 1 BLISTER PACK 7 pouch 2005-02-01 0000-00-00 No No Current