Home NDC 0168-0099 ketoconazole
Product NDC 0168-0099
11-digit product format 001680099
Labeler code 0168
Product ID 0168-0099_6eaf555f-3e9c-4811-ae1f-66afda8b2b11
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ketoconazole
Dosage form CREAM
Route TOPICAL
Labeler E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application ANDA076294
Marketing category ANDA
Marketing start 2004-04-28
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 2027-12-31
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 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.
Additional Listing Data#
Finished product Yes
Brand name base ketoconazole
Listing expiration 2027-12-31 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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ketoconazole ACTIVE INGREDIENT R9400W927I KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 ketoconazole ACTIVE MOIETY R9400W927I KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 isopropyl myristate INACTIVE INGREDIENT 0RE8K4LNJS KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 sodium sulfite INACTIVE INGREDIENT VTK01UQK3G KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 sorbitan monostearate INACTIVE INGREDIENT NVZ4I0H58X KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 KETOCONAZOLE ACTIVE INGREDIENT R9400W927I KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 KETOCONAZOLE ACTIVE INGREDIENT R9400W927I KETOCONAZOLE CREAM [DIRECT RX] 1 KETOCONAZOLE ACTIVE MOIETY R9400W927I KETOCONAZOLE CREAM [DIRECT RX] 1 KETOCONAZOLE ACTIVE MOIETY R9400W927I KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN KETOCONAZOLE CREAM [DIRECT RX] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 isopropyl myristate INACTIVE INGREDIENT 0RE8K4LNJS KETOCONAZOLE CREAM [DIRECT RX] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M KETOCONAZOLE CREAM [DIRECT RX] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H KETOCONAZOLE CREAM [DIRECT RX] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 KETOCONAZOLE CREAM [DIRECT RX] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 sodium sulfite INACTIVE INGREDIENT VTK01UQK3G KETOCONAZOLE CREAM [DIRECT RX] 1 SODIUM SULFITE INACTIVE INGREDIENT VTK01UQK3G KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 sorbitan monostearate INACTIVE INGREDIENT NVZ4I0H58X KETOCONAZOLE CREAM [DIRECT RX] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y KETOCONAZOLE CREAM [DIRECT RX] 1 water INACTIVE INGREDIENT 059QF0KO0R KETOCONAZOLE CREAM [DIRECT RX] 1 WATER INACTIVE INGREDIENT 059QF0KO0R KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0168-0099 KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 7 Current NDC, Legacy NDC, 6 package rows 20211020_cad7c647-34a9-4e4e-83b3-8d78e58f588f.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 ndc (product): 0168-0099
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 0168-0099-15 00168009915 1 TUBE in 1 CARTON (0168-0099-15) / 15 g in 1 TUBE 1 tube 2004-04-28 0000-00-00 No No Current 0168-0099-30 00168009930 1 TUBE in 1 CARTON (0168-0099-30) / 30 g in 1 TUBE 1 tube 2004-04-28 0000-00-00 No No Current 0168-0099-60 00168009960 1 TUBE in 1 CARTON (0168-0099-60) / 60 g in 1 TUBE 1 tube 2004-04-28 0000-00-00 No No Current