Home NDC 70518-1637 ketoconazole
Product NDC 70518-1637
11-digit product format 705181637
Labeler code 70518
Product ID 70518-1637_9618003a-98c0-ed31-e053-2995a90a896a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ketoconazole
Dosage form CREAM
Route TOPICAL
Labeler REMEDYREPACK INC.
Application ANDA076294
Marketing category ANDA
Marketing start 2018-11-06
Marketing end 0000-00-00
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 2020-12-31
Current FDA listing Historical FDA.report record 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 · 4 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-1637-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-1637-0 f5e01cc5f278…a2eaf40c39c3…
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 A076294-001 KETOCONAZOLE KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076294-001 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 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-1637 KETOCONAZOLE CREAM [REMEDYREPACK INC.] 7 Legacy NDC 20250226_c394914b-2334-418e-bf86-9f9100323717.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ketoconazole KETOCONAZOLE E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC cad7c647-34a9-4e4e-83b3-8d78e58f588f 2026-01-28 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076294 application number: ANDA076294