Home NDC 69339-159 Itraconazole Oral
Product NDC 69339-159
11-digit product format 693390159
Labeler code 69339
Product ID 69339-159_2af07b39-fe93-4961-90cb-ed9c5e2f424d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Itraconazole
Dosage form SOLUTION
Route ORAL
Labeler Natco Pharma USA LLC
Application ANDA212239
Marketing category ANDA
Marketing start 2022-04-25
Substance ITRACONAZOLE
Active strength 10 mg/mL
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 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 A212239-001 ITRACONAZOLE ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212239-001 AA
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.
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 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212239-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2020-09-01 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Itraconazole Oral
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ITRACONAZOLE 10 mg/mL
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 348506 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 69339-159-01 Itraconazole Oral 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 2 69339-159-17 Itraconazole Oral 40 in 1 BOX, UNIT-DOSE SOLUTION 40 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69339-159 ITRACONAZOLE ORAL (ITRACONAZOLE) SOLUTION [NATCO PHARMA USA LLC] 2 Current NDC, Legacy NDC, 2 package rows 20230902_da63870d-b426-4e49-9591-5bb51f962e66.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 69339-159-01 69339015901 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical 69339-159-17 69339015917 40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-159-17) / 10 mL in 1 CUP, UNIT-DOSE (69339-159-01) 2022-04-25 0000-00-00 No No Current