Home NDC 68071-1709 Ketoconazole
Product NDC 68071-1709
11-digit product format 680711709
Labeler code 68071
Product ID 68071-1709_2a321ff6-d67f-0fca-e063-6394a90a8644
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketoconazole
Dosage form CREAM
Route TOPICAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA075638
Marketing category ANDA
Marketing start 2002-12-18
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 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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68071-1709-3 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-1709-3 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-1709-3 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-1709-3 1332a3947898…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075638-001 KETOZOLE KETOCONAZOLE 2% CREAM / TOPICAL AB 2002-12-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075638-001 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 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075638-001 KETOZOLE 2% CREAM / TOPICAL AB 2002-12-18 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-1709-3 Ketoconazole 30 g in 1 BOX CREAM 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-1709 KETOCONAZOLE CREAM [NUCARE PHARMACEUTICALS,INC.] 6 Current NDC, Legacy NDC, 1 package rows 20241228_570acb82-0c6f-0b98-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 · 6 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ketoconazole KETOCONAZOLE NORTHSTAR RX LLC bf3e48fd-e063-42e6-acd1-580ddc6e93be 2026-01-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075638 application number: ANDA075638 Ketoconazole KETOCONAZOLE Golden State Medical Supply, Inc. 3e3cde4b-939f-4837-9920-bb6bb8416bd6 2025-07-10 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075638 application number: ANDA075638 Ketoconazole KETOCONAZOLE Sun Pharmaceutical Industries, Inc. 39b85d6a-9133-42e6-b7f8-58f045e9b9f0 2025-07-07 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075638 application number: ANDA075638 Ketoconazole KETOCONAZOLE NuCare Pharmaceuticals,Inc. 570acb82-0c6f-0b98-e054-00144ff8d46c 2024-12-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075638 application number: ANDA075638 ndc (product): 68071-1709 Ketoconazole KETOCONAZOLE A-S Medication Solutions 8ef1117d-0b63-4c26-beaa-7667b2387e14 2023-11-17 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075638 application number: ANDA075638 Ketoconazole KETOCONAZOLE Proficient Rx LP 4f08caf2-a57c-4146-9289-532711bbdbcd 2022-04-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075638 application number: ANDA075638
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 68071-1709-3 68071170903 30 g in 1 BOX (68071-1709-3) 30 g 2017-08-18 0000-00-00 No No Current