Home NDC 64380-827 KETOCONAZOLE
Product NDC 64380-827
11-digit product format 643800827
Labeler code 64380
Product ID 64380-827_9781ff7c-39a7-4c61-a6ec-7f1947685c6b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name KETOCONAZOLE
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA210457
Marketing category ANDA
Marketing start 2018-06-26
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 2027-12-31
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 A210457-001 KETOCONAZOLE KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210457-001 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 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210457-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2018-06-18 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 KETOCONAZOLE
Listing expiration 2027-12-31 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 64380-827-06 KETOCONAZOLE 100 in 1 BOTTLE TABLET 100 8 64380-827-07 KETOCONAZOLE 500 in 1 BOTTLE TABLET 500 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-827 KETOCONAZOLE TABLET [STRIDES PHARMA SCIENCE LIMITED] 7 Current NDC, Legacy NDC, 2 package rows 20230713_6d4be760-c723-4f54-a854-12c61cf91703.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 64380-827-06 64380082706 100 TABLET in 1 BOTTLE (64380-827-06) 100 tablet 2018-06-26 0000-00-00 No No Current 64380-827-07 64380082707 500 TABLET in 1 BOTTLE (64380-827-07) 500 tablet 2018-06-26 0000-00-00 No No Current