Home NDC 50090-5265 Ketoconazole
Product NDC 50090-5265
11-digit product format 500905265
Labeler code 50090
Product ID 50090-5265_feb1a21d-ab6a-4015-99c2-e55a098a10f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketoconazole
Dosage form CREAM
Route TOPICAL
Labeler A-S Medication Solutions
Application ANDA075581
Marketing category ANDA
Marketing start 2019-02-08
Substance KETOCONAZOLE
Active strength 20 mg/g
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 1 .
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 A075581-001 KETOCONAZOLE KETOCONAZOLE 2% CREAM / TOPICAL AB 2000-04-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075581-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2000-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2000-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075581-001 KETOCONAZOLE 2% CREAM / TOPICAL AB RS 2000-04-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 20 mg/g
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 203088 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 50090-5265-0 Ketoconazole 15 g in 1 TUBE CREAM 15 5 50090-5265-0 Ketoconazole 1 in 1 CARTON CREAM 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5265 KETOCONAZOLE CREAM [A-S MEDICATION SOLUTIONS] 5 Current NDC, Legacy NDC, 2 package rows 20240110_b3b99c8b-4512-4972-935d-602d4b8325c4.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.
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 50090-5265-0 50090526500 1 TUBE in 1 CARTON (50090-5265-0) / 15 g in 1 TUBE 1 tube 2020-10-16 0000-00-00 No No Current