Ketoconazole

Product NDC
50090-1220
11-digit product format
500901220
Labeler code
50090
Product ID
50090-1220_872126b2-e2bb-4a0f-aa98-d7c143fb5d0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoconazole
Dosage form
SHAMPOO, SUSPENSION
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA076419
Marketing category
ANDA
Marketing start
2010-01-19
Marketing end
0000-00-00
Substance
KETOCONAZOLE
Active strength
20 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 productproduct50090-1220IInactivated by FDA2026-08-11
excluded packagepackage50090-122050090-1220-0IInactivated by FDA2026-08-11

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 packagepackage50090-1220-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-1220-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-1220-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-1220-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-1220-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-1220-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-1220-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-1220-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-1220-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-1220-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-1220-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-1220-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-1220-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-1220-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-1220-01332a3947898…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
A076419-001KETOCONAZOLEKETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076419-001AB

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 UTC2026-02A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2004-01-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2004-01-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2004-01-073f01610625f2…
2019-09-15 20:21 UTC2019-09A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2004-01-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2004-01-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076419-001KETOCONAZOLE2%SHAMPOO / TOPICALABRS2004-01-07cb3db0bc1861…

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 UTC2026-02A076419-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076419-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076419-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076419-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076419-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076419-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076419-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076419-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076419-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076419-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076419-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076419-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076419-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076419-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076419-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076419-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076419-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076419-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076419-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076419-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076419-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076419-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076419-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076419-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076419-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076419-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076419-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076419-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076419-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076419-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076419-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076419-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076419-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076419-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076419-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076419-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076419-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076419-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076419-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076419-001AB1cb3db0bc1861…

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
50090-1220-02023-01-30C16284748780-1f386c649-ab4b-0266-e053-dadaa90a7c1aKetoconazole Shampoo, 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1220-0Ketoconazole120 mL in 1 BOTTLESHAMPOO, SUSPENSION12010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1220-0ML - Milliliter50090-12205bbecd7c-10c2-4835-9054-ebed1b7441d412018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1220KETOCONAZOLE SHAMPOO, SUSPENSION [A-S MEDICATION SOLUTIONS]10Legacy NDC, 1 package rows20210223_2c5e02ba-c165-4ffb-bd05-fbd4243725b7.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KetoconazoleKETOCONAZOLENuCare Pharmaceuticals, Inc.53492ad1-baca-a7f6-e063-6294a90a29902026-06-02Adverse reactionsExact identifier
application applno (ANDA): 076419
application number: ANDA076419
KetoconazoleKETOCONAZOLENuCare Pharmaceuticals,Inc.4578c84a-d438-6740-e063-6294a90a01512025-12-08Adverse reactionsExact identifier
application applno (ANDA): 076419
application number: ANDA076419
KetoconazoleKETOCONAZOLENorthstar Rx LLCc4f711dc-d0ea-4beb-9a78-b7e3594ee4be2025-12-01Adverse reactionsExact identifier
application applno (ANDA): 076419
application number: ANDA076419
KetoconazoleKETOCONAZOLEBryant Ranch Prepack6d394f8c-d49e-45ff-b7a9-a14aba9bb9cf2025-10-24Adverse reactionsExact identifier
application applno (ANDA): 076419
application number: ANDA076419
KetoconazoleKETOCONAZOLEBryant Ranch Prepackd0fcab34-5451-456a-a75a-b1365d5dbc2c2024-06-20Adverse reactionsExact identifier
application applno (ANDA): 076419
application number: ANDA076419
KetoconazoleKETOCONAZOLEPadagis Israel Pharmaceuticals Ltd99da5233-2760-46f6-8fb3-d9df5da70bfb2024-05-31Adverse reactionsExact identifier
application applno (ANDA): 076419
application number: ANDA076419
KetoconazoleKETOCONAZOLEBryant Ranch Prepackb200ef76-5ea1-4253-bea5-1e8db02945102024-03-15Adverse reactionsExact identifier
application applno (ANDA): 076419
application number: ANDA076419

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106336ketoconazole 2 % Medicated ShampooPSN2c5e02ba-c165-4ffb-bd05-fbd4243725b710
106336ketoconazole 20 MG/ML Medicated ShampooSCD2c5e02ba-c165-4ffb-bd05-fbd4243725b710
106336ketoconazole 2 % Medicated ShampooSY2c5e02ba-c165-4ffb-bd05-fbd4243725b710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1220-050090122000120 mL in 1 BOTTLE (50090-1220-0) 120 ml2014-11-280000-00-00NoNoCurrent