Ketoconazole

Product NDC
68071-1735
11-digit product format
680711735
Labeler code
68071
Product ID
68071-1735_bb17da97-c264-3443-e053-2995a90a3bb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoconazole
Dosage form
SHAMPOO, SUSPENSION
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA076942
Marketing category
ANDA
Marketing start
2016-10-01
Marketing end
0000-00-00
Substance
KETOCONAZOLE
Active strength
21 mg/mL
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-1735IInactivated by FDA2026-08-03
excluded packagepackage68071-173568071-1735-4IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-1735-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-1735-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-1735-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-1735-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-1735-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-1735-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-1735-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-1735-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-1735-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-1735-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-1735-4367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-1735-4557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-1735-48af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-1735-4834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-1735-41332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076942-001KETOCONAZOLEKETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076942-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-113f01610625f2…
2019-09-15 20:21 UTC2019-09A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076942-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2005-04-11cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076942-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076942-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076942-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076942-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076942-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076942-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076942-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076942-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076942-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076942-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076942-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076942-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076942-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076942-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076942-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076942-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076942-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076942-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076942-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076942-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076942-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076942-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076942-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076942-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076942-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076942-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076942-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076942-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076942-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076942-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076942-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076942-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076942-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076942-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076942-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076942-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076942-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076942-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076942-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076942-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-1735-42023-01-30C16284748780-1ba0f9c33-12a2-a910-e053-dadaa90a0b85Ketoconazole Shampoo
68071-1735-42021-02-11C16284748780-1ba0f9c33-12a2-a910-e053-dadaa90a0b85Ketoconazole Shampoo
68071-1735-42021-01-29C16284748780-1ba0f9c33-12a2-a910-e053-dadaa90a0b85Ketoconazole Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1735-4Ketoconazole120 mL in 1 BOTTLESHAMPOO, SUSPENSION1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1735KETOCONAZOLE SHAMPOO, SUSPENSION [NUCARE PHARMACEUTICALS,INC.]4Legacy NDC, 1 package rows20210212_54c69554-0b09-27e7-e054-00144ff8d46c.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KetoconazoleKETOCONAZOLEPreferred Pharmaceuticals Inc.d59df5bf-bfa6-45fa-81f6-8c8ee2f24cf82026-05-14Adverse reactionsExact identifier
application applno (ANDA): 076942
application number: ANDA076942
KetoconazoleKETOCONAZOLETHIRTY MADISON INC1f5cd9f4-0db4-4062-b5ec-c33611265e022025-12-17Adverse reactionsExact identifier
application applno (ANDA): 076942
application number: ANDA076942
KetoconazoleKETOCONAZOLEPreferred Pharmaceuticals Inc.39d31bed-9caa-41bb-afdb-25fc18609c142025-04-24Adverse reactionsExact identifier
application applno (ANDA): 076942
application number: ANDA076942
KetoconazoleKETOCONAZOLEA-S Medication Solutionsa884bad7-df8c-45de-8c4f-42034b40e4252025-04-23Adverse reactionsExact identifier
application applno (ANDA): 076942
application number: ANDA076942
KetoconazoleKETOCONAZOLECosette Pharmaceuticals, Inc.2d7c8dd1-59b5-2645-e063-6394a90a5bda2025-02-06Adverse reactionsExact identifier
application applno (ANDA): 076942
application number: ANDA076942
KetoconazoleKETOCONAZOLEA-S Medication Solutionsc29d4ddc-aa1c-41c6-99ce-9aff35d213f62023-09-25Adverse reactionsExact identifier
application applno (ANDA): 076942
application number: ANDA076942
KetoconazoleKETOCONAZOLEProficient Rx LPcb1908da-443d-40b8-b8c7-b115bc2d37e02022-11-01Adverse reactionsExact identifier
application applno (ANDA): 076942
application number: ANDA076942
KetoconazoleKETOCONAZOLETOLMAR Inc.7036d1f2-c3f9-41d4-bc72-dd70e16911282020-06-03Adverse reactionsExact identifier
application applno (ANDA): 076942
application number: ANDA076942

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106336ketoconazole 2 % Medicated ShampooPSN54c69554-0b09-27e7-e054-00144ff8d46c4
106336ketoconazole 20 MG/ML Medicated ShampooSCD54c69554-0b09-27e7-e054-00144ff8d46c4
106336ketoconazole 2 % Medicated ShampooSY54c69554-0b09-27e7-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1735-468071173504120 mL in 1 BOTTLE (68071-1735-4) 120 ml2017-07-200000-00-00NoNoCurrent