Home NDC 62332-204 ITRACONAZOLE
Product NDC 62332-204
11-digit product format 623320204
Labeler code 62332
Product ID 62332-204_981e1db1-8bfd-4aa6-8a8e-5e9d6ec42a15
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name itraconazole
Dosage form CAPSULE
Route ORAL
Labeler Alembic Pharmaceuticals Inc.
Application ANDA206741
Marketing category ANDA
Marketing start 2016-12-16
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A206741-001 ITRACONAZOLE 100MG CAPSULE / ORAL AB 2016-12-13 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 A206741-001 AB 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206741-001 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206741-001 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206741-001 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ITRACONAZOLE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ITRACONAZOLE 100 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62332-204 ITRACONAZOLE CAPSULE [ALEMBIC PHARMACEUTICALS INC.] 25 Current NDC, Legacy NDC, 5 package rows 20250323_23126370-8d6a-4027-bd8f-860e2776ba3a.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 Alembic Pharmaceuticals Limited f9d8b5a7-435f-40e6-8596-5f2376b92c74 2023-01-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206741 application number: ANDA206741
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 62332-204-04 62332020404 28 CAPSULE in 1 CARTON (62332-204-04) 28 capsule 2016-12-16 0000-00-00 No No Current 62332-204-10 62332020410 100 CAPSULE in 1 CARTON (62332-204-10) 100 capsule 2016-12-16 0000-00-00 No No Current 62332-204-30 62332020430 30 CAPSULE in 1 BOTTLE (62332-204-30) 30 capsule 2016-12-16 0000-00-00 No No Current 62332-204-71 62332020471 500 CAPSULE in 1 BOTTLE (62332-204-71) 500 capsule 2016-12-16 0000-00-00 No No Current 62332-204-90 62332020490 90 CAPSULE in 1 BOTTLE (62332-204-90) 90 capsule 2016-12-16 0000-00-00 No No Current