Home NDC 35573-433 KETOCONAZOLE
Product NDC 35573-433
11-digit product format 355730433
Labeler code 35573
Product ID 35573-433_748e48d8-09d3-413c-b724-883b6b47f01e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ketoconazole
Dosage form TABLET
Route ORAL
Labeler Burel Pharmaceuticals, LLC
Application ANDA075912
Marketing category ANDA
Marketing start 2020-04-10
Substance KETOCONAZOLE
Active strength 200 mg/1
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 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 1 .
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 A075912-001 KETOCONAZOLE KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075912-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL 2002-01-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL 2002-01-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL 2002-01-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL 2002-01-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075912-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2002-01-10 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base KETOCONAZOLE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETOCONAZOLE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R9400W927I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197853 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 35573-433-02 KETOCONAZOLE 100 in 1 BOTTLE TABLET 100 5 35573-433-30 KETOCONAZOLE 30 in 1 BOTTLE TABLET 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35573-433 KETOCONAZOLE TABLET [BUREL PHARMACEUTICALS, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20230805_57e81e13-b395-4dbd-b660-3038de41a838.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ketoconazole KETOCONAZOLE Amici Pharma Inc. 369f31da-d3c3-49b8-956f-f70598760164 2025-06-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075912 application number: ANDA075912 KETOCONAZOLE KETOCONAZOLE Direct Rx bc189ce2-3f10-260d-e053-2a95a90ae808 2025-01-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075912 application number: ANDA075912 KETOCONAZOLE KETOCONAZOLE Bryant Ranch Prepack 3ea8a22b-cd61-4623-a11f-43e3396b50fa 2024-05-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075912 application number: ANDA075912 KETOCONAZOLE KETOCONAZOLE A-S Medication Solutions 517c29fc-2a2a-4bd5-a8bb-b464a65d2be0 2023-11-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075912 application number: ANDA075912 KETOCONAZOLE KETOCONAZOLE Burel Pharmaceuticals, LLC 57e81e13-b395-4dbd-b660-3038de41a838 2023-08-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075912 application number: ANDA075912 ndc (product): 35573-433
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 35573-433-02 35573043302 100 TABLET in 1 BOTTLE (35573-433-02) 100 tablet 2020-04-10 0000-00-00 No No Current 35573-433-30 35573043330 30 TABLET in 1 BOTTLE (35573-433-30) 30 tablet 2020-04-10 0000-00-00 No No Current