Home NDC 51672-4026 Ketoconazole
Product NDC 51672-4026
11-digit product format 516724026
Labeler code 51672
Product ID 51672-4026_3dd44662-95fb-0d34-e063-6294a90a5fbc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketoconazole
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Ketoconazole ACTIVE INGREDIENT R9400W927I KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 5 Ketoconazole ACTIVE MOIETY R9400W927I KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 5 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 5 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 5 magnesium stearate INACTIVE INGREDIENT 70097M6I30 KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 5 povidones INACTIVE INGREDIENT FZ989GH94E KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 5 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 5 starch, corn INACTIVE INGREDIENT O8232NY3SJ KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 5 Ketoconazole ACTIVE INGREDIENT R9400W927I KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 Ketoconazole ACTIVE MOIETY R9400W927I KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 colloidal silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 povidone INACTIVE INGREDIENT FZ989GH94E KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 Ketoconazole ACTIVE INGREDIENT R9400W927I KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 Ketoconazole ACTIVE MOIETY R9400W927I KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 povidones INACTIVE INGREDIENT FZ989GH94E KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 starch, corn INACTIVE INGREDIENT O8232NY3SJ KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 KETOCONAZOLE ACTIVE INGREDIENT R9400W927I KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 KETOCONAZOLE ACTIVE INGREDIENT R9400W927I KETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 Ketoconazole ACTIVE INGREDIENT R9400W927I KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] 1 KETOCONAZOLE ACTIVE MOIETY R9400W927I KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 KETOCONAZOLE ACTIVE MOIETY R9400W927I KETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 Ketoconazole ACTIVE MOIETY R9400W927I KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U KETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X KETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 KETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E KETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 povidone INACTIVE INGREDIENT FZ989GH94E KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 KETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ KETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4026 KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 11 Current NDC, Legacy NDC, 9 package rows 20240524_8ca815a8-bccb-4ee2-a042-922373329cae.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 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 ndc (product): 51672-4026 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 51672-4026-0 51672402600 10 BLISTER PACK in 1 BOX (51672-4026-0) / 10 TABLET in 1 BLISTER PACK 10 blister pack 1999-06-15 0000-00-00 No No Current 51672-4026-1 51672402601 100 TABLET in 1 BOTTLE (51672-4026-1) 100 tablet 1999-06-15 0000-00-00 No No Current 51672-4026-2 51672402602 500 TABLET in 1 BOTTLE (51672-4026-2) 500 tablet 1999-06-15 0000-00-00 No No Current 51672-4026-6 51672402606 30 TABLET in 1 BOTTLE (51672-4026-6) 30 tablet 1999-06-15 2026-08-31 No No Current 51672-4026-8 51672402608 3 BLISTER PACK in 1 BOX (51672-4026-8) / 10 TABLET in 1 BLISTER PACK 3 blister pack 1999-06-15 0000-00-00 No No Current 51672-4026-9 51672402609 5 BLISTER PACK in 1 BOX (51672-4026-9) / 10 TABLET in 1 BLISTER PACK 5 blister pack 1999-06-15 0000-00-00 No No Current