Home NDC 71335-0439 Ketoconazole
Product NDC 71335-0439
11-digit product format 713350439
Labeler code 71335
Product ID 71335-0439_ae8e3f89-1b77-4934-9252-64d9888d13fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketoconazole
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA075319
Marketing category ANDA
Marketing start 1999-06-15
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 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 A075319-001 KETOCONAZOLE KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075319-001 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 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075319-001 KETOCONAZOLE 200MG TABLET / ORAL AB RS 1999-06-15 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 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0439 KETOCONAZOLE TABLET [BRYANT RANCH PREPACK] 10 Current NDC, Legacy NDC, 8 package rows 20240524_4baebcab-a237-42c0-9183-6f447a44e371.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ketoconazole KETOCONAZOLE Bryant Ranch Prepack 4baebcab-a237-42c0-9183-6f447a44e371 2025-11-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075319 application number: ANDA075319 ndc (product): 71335-0439 Ketoconazole KETOCONAZOLE Golden State Medical Supply, Inc. a9fc4618-4d87-47ef-ab3c-c9ffac3ba9b7 2025-11-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075319 application number: ANDA075319 Ketoconazole KETOCONAZOLE Sun Pharmaceutical Industries, Inc. 8ca815a8-bccb-4ee2-a042-922373329cae 2025-09-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075319 application number: ANDA075319 Ketoconazole KETOCONAZOLE Direct_Rx f5dc1e67-639f-5476-e053-2995a90a4210 2025-01-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075319 application number: ANDA075319
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 71335-0439-1 71335043901 10 TABLET in 1 BOTTLE (71335-0439-1) 10 tablet 2010-04-28 0000-00-00 No No Current 71335-0439-2 71335043902 30 TABLET in 1 BOTTLE (71335-0439-2) 30 tablet 2010-04-28 0000-00-00 No No Current 71335-0439-3 71335043903 40 TABLET in 1 BOTTLE (71335-0439-3) 40 tablet 2010-04-28 0000-00-00 No No Current 71335-0439-4 71335043904 60 TABLET in 1 BOTTLE (71335-0439-4) 60 tablet 2010-04-28 0000-00-00 No No Current 71335-0439-5 71335043905 8 TABLET in 1 BOTTLE (71335-0439-5) 8 tablet 2010-04-28 0000-00-00 No No Current 71335-0439-6 71335043906 7 TABLET in 1 BOTTLE (71335-0439-6) 7 tablet 2010-04-28 0000-00-00 No No Current 71335-0439-7 71335043907 14 TABLET in 1 BOTTLE (71335-0439-7) 14 tablet 2010-04-28 0000-00-00 No No Current 71335-0439-8 71335043908 90 TABLET in 1 BOTTLE (71335-0439-8) 90 tablet 2010-04-28 0000-00-00 No No Current