Home NDC 65162-087 Itraconazole
Product NDC 65162-087
11-digit product format 651620087
Labeler code 65162
Product ID 65162-087_fabca3d3-1b0c-48a3-bd56-5e5a11b1fb3b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Itraconazole
Dosage form SOLUTION
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA205573
Marketing category ANDA
Marketing start 2014-04-30
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 A205573-001 ITRACONAZOLE ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA RS 2015-10-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205573-001 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.
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 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA RS 2015-10-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA RS 2015-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA RS 2015-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205573-001 ITRACONAZOLE 10MG/ML SOLUTION / ORAL AA 2015-10-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 A205573-001 PC 2019-03-17 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 A205573-001 PC 2019-03-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205573-001 PC 2019-03-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205573-001 PC 2019-03-17 ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Itraconazole
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 65162-087-13 Itraconazole 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 19 65162-087-34 Itraconazole 10 in 1 TRAY SOLUTION 10 19 65162-087-74 Itraconazole 150 mL in 1 BOTTLE, GLASS SOLUTION 150 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-087 ITRACONAZOLE SOLUTION [AMNEAL PHARMACEUTICALS LLC] 19 Current NDC, Legacy NDC, 3 package rows 20250119_43ded1aa-f825-40fe-aa9a-addd36a07f06.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 Marketing end Sample Exclude flag Status 65162-087-13 65162008713 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical 65162-087-34 65162008734 10 CUP, UNIT-DOSE in 1 TRAY (65162-087-34) / 10 mL in 1 CUP, UNIT-DOSE (65162-087-13) 2014-04-30 0000-00-00 No No Current 65162-087-74 65162008774 150 mL in 1 BOTTLE, GLASS (65162-087-74) 150 ml 2014-04-30 0000-00-00 No No Current