Ketodan

Product NDC
43538-530
11-digit product format
435380530
Labeler code
43538
Product ID
43538-530_354d4926-b665-4e7e-a86a-5baae165a470
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketoconazole
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Medimetriks Pharmaceuticals, Inc.
Application
ANDA091550
Marketing category
ANDA
Marketing start
2012-06-15
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091550-001KETOCONAZOLEKETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A091550-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAT2011-08-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAT2011-08-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAT2011-08-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAT2011-08-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAT2011-08-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAT2011-08-253f01610625f2…
2019-09-15 20:21 UTC2019-09A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAT2011-08-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAT2011-08-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-25cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091550-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091550-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091550-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091550-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091550-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091550-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091550-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091550-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091550-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091550-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091550-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091550-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091550-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091550-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091550-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091550-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091550-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091550-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091550-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091550-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091550-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A091550-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091550-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091550-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091550-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A091550-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091550-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091550-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091550-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091550-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091550-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091550-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091550-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091550-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091550-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091550-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091550-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091550-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091550-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091550-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Ketodan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOCONAZOLE20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R9400W927IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
728550Internal RxNorm lookup
1300272Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
62f19bd8-926e-4e6b-9097-d81b894b95ccAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43538-530-10Ketodan100 g in 1 CANAEROSOL, FOAM1008
43538-530-10Ketodan1 in 1 CARTONAEROSOL, FOAM18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43538-530-10GM - Gram43538-530337a3162-6695-4d73-bf80-f35625b85c9212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ketoconazoleACTIVE INGREDIENTR9400W927IKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
ketoconazoleACTIVE MOIETYR9400W927IKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
alcoholINACTIVE INGREDIENT3K9958V90MKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
brucine sulfateINACTIVE INGREDIENTKY7O12XPOQKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
butaneINACTIVE INGREDIENT6LV4FOR43RKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
potassium citrateINACTIVE INGREDIENTEE90ONI6FFKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
propaneINACTIVE INGREDIENTT75W9911L6KETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3KETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
tert-butyl alcoholINACTIVE INGREDIENTMD83SFE959KETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43538-530KETODAN (KETOCONAZOLE) AEROSOL, FOAM [MEDIMETRIKS PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 2 package rows20241207_62f19bd8-926e-4e6b-9097-d81b894b95cc.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ketoconazoleKETOCONAZOLEBryant Ranch Prepacka878a39d-6d26-4ede-9667-b3e201ffc3372025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091550
application number: ANDA091550
ketoconazoleKETOCONAZOLEBryant Ranch Prepack65dd4435-99f2-4383-b307-ba5bce9f1ca92025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091550
application number: ANDA091550
ketoconazoleKETOCONAZOLEBryant Ranch Prepackac98307e-315a-4fbd-81cb-cd936f2bfbae2024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091550
application number: ANDA091550
KetodanKETOCONAZOLEMedimetriks Pharmaceuticals, Inc.62f19bd8-926e-4e6b-9097-d81b894b95cc2024-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091550
application number: ANDA091550
ndc (product): 43538-530
ketoconazoleKETOCONAZOLEBryant Ranch Prepack77989858-9f7a-45d6-97fb-deba1cba8fe82024-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091550
application number: ANDA091550
ketoconazoleKETOCONAZOLEBryant Ranch Prepack513370d5-2e9f-4677-a0f2-63ff761429092024-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091550
application number: ANDA091550
ketoconazoleKETOCONAZOLEPadagis Israel Pharmaceuticals Ltd9b65f632-a98d-400e-9ec3-84dea581d6a32024-02-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091550
application number: ANDA091550

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728550ketoconazole 2 % Topical FoamPSN62f19bd8-926e-4e6b-9097-d81b894b95cc8
1300272Ketodan 2 % Topical FoamPSN62f19bd8-926e-4e6b-9097-d81b894b95cc8
1300272ketoconazole 20 MG/ML Topical Foam [Ketodan]SBD62f19bd8-926e-4e6b-9097-d81b894b95cc8
728550ketoconazole 20 MG/ML Topical FoamSCD62f19bd8-926e-4e6b-9097-d81b894b95cc8
728550ketoconazole 2 % Topical FoamSY62f19bd8-926e-4e6b-9097-d81b894b95cc8
1300272Ketodan 2 % Topical FoamSY62f19bd8-926e-4e6b-9097-d81b894b95cc8
1300272Ketodan 20 MG/ML Topical FoamSY62f19bd8-926e-4e6b-9097-d81b894b95cc8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43538-530-10435380530101 CAN in 1 CARTON (43538-530-10) / 100 g in 1 CAN1 can2012-06-150000-00-00NoNoCurrent