Home NDC 70700-160 Ketoconazole
Product NDC 70700-160
11-digit product format 707000160
Labeler code 70700
Product ID 70700-160_1d2842b4-06d6-8054-d485-cb30f0ed4f69
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketoconazole Foam
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler Xiromed, LLC
Application ANDA213601
Marketing category ANDA
Marketing start 2021-05-21
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 A213601-001 KETOCONAZOLE KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB RS 2021-05-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213601-001 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.
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 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB RS 2021-05-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB RS 2021-05-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB RS 2021-05-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB RS 2021-05-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB RS 2021-05-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB RS 2021-05-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB RS 2021-05-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB RS 2021-05-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB RS 2021-05-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB RS 2021-05-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB RS 2021-05-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB RS 2021-05-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB RS 2021-05-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB RS 2021-05-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB 2021-05-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB 2021-05-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB 2021-05-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB 2021-05-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB 2021-05-21 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB RS 2021-05-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB 2021-05-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB 2021-05-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB 2021-05-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB 2021-05-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB 2021-05-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB 2021-05-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB 2021-05-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB 2021-05-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB 2021-05-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB 2021-05-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB 2021-05-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB 2021-05-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213601-001 KETOCONAZOLE 2% AEROSOL, FOAM / TOPICAL AB RS 2021-05-21 a50c72e98297…
Observed Orange Book normalized TE history# 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 728550 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 70700-160-19 Ketoconazole 50 g in 1 CAN AEROSOL, FOAM 50 9 70700-160-20 Ketoconazole 100 g in 1 CAN AEROSOL, FOAM 100 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70700-160 KETOCONAZOLE (KETOCONAZOLE FOAM ) AEROSOL, FOAM [XIROMED, LLC] 9 Current NDC, Legacy NDC, 2 package rows 20230707_ea319889-5e58-f778-3009-5ba6a5f2690a.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.
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 70700-160-19 70700016019 50 g in 1 CAN (70700-160-19) 50 g 2021-05-21 0000-00-00 No No Current 70700-160-20 70700016020 100 g in 1 CAN (70700-160-20) 100 g 2021-05-21 0000-00-00 No No Current