ketoconazole

Product NDC
45802-532
11-digit product format
458020532
Labeler code
45802
Product ID
45802-532_f9768109-216c-49f3-be2a-d0c3eac142b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketoconazole
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA091550
Marketing category
ANDA
Marketing start
2011-08-30
Substance
KETOCONAZOLE
Active strength
2 g/100g
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 42.

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091550-001KETOCONAZOLE2%AEROSOL, FOAM / TOPICALAB2011-08-25caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A091550-001AB1caaa826d4ba7…
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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOCONAZOLE2 g/100g

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9b65f632-a98d-400e-9ec3-84dea581d6a3Available 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
45802-532-32ketoconazole1 in 1 CARTONAEROSOL, FOAM18
45802-532-32ketoconazole50 g in 1 CANISTERAEROSOL, FOAM508
45802-532-33ketoconazole1 in 1 CARTONAEROSOL, FOAM18
45802-532-33ketoconazole100 g in 1 CANISTERAEROSOL, FOAM1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-532-32GM - Gram45802-5326f99625b-0a8a-4c91-ad67-e2666f6a8b8d12012-07-24
45802-532-33GM - Gram45802-53280e1ea2e-b379-4a19-8b77-e4d9b2b0656012012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-532KETOCONAZOLE AEROSOL, FOAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]8Current NDC, Legacy NDC, 4 package rows20240921_9b65f632-a98d-400e-9ec3-84dea581d6a3.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
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
ndc (product): 45802-532

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728550ketoconazole 2 % Topical FoamPSN513370d5-2e9f-4677-a0f2-63ff76142909105
728550ketoconazole 2 % Topical FoamPSN77989858-9f7a-45d6-97fb-deba1cba8fe8105
728550ketoconazole 20 MG/ML Topical FoamSCD513370d5-2e9f-4677-a0f2-63ff76142909105
728550ketoconazole 20 MG/ML Topical FoamSCD77989858-9f7a-45d6-97fb-deba1cba8fe8105
728550ketoconazole 2 % Topical FoamSY513370d5-2e9f-4677-a0f2-63ff76142909105
728550ketoconazole 2 % Topical FoamSY77989858-9f7a-45d6-97fb-deba1cba8fe8105
728550ketoconazole 2 % Topical FoamPSNac98307e-315a-4fbd-81cb-cd936f2bfbae100
728550ketoconazole 2 % Topical FoamPSNa878a39d-6d26-4ede-9667-b3e201ffc337100
728550ketoconazole 2 % Topical FoamPSN65dd4435-99f2-4383-b307-ba5bce9f1ca9100
728550ketoconazole 20 MG/ML Topical FoamSCD65dd4435-99f2-4383-b307-ba5bce9f1ca9100
728550ketoconazole 20 MG/ML Topical FoamSCDa878a39d-6d26-4ede-9667-b3e201ffc337100
728550ketoconazole 20 MG/ML Topical FoamSCDac98307e-315a-4fbd-81cb-cd936f2bfbae100
728550ketoconazole 2 % Topical FoamSYa878a39d-6d26-4ede-9667-b3e201ffc337100
728550ketoconazole 2 % Topical FoamSYac98307e-315a-4fbd-81cb-cd936f2bfbae100
728550ketoconazole 2 % Topical FoamSY65dd4435-99f2-4383-b307-ba5bce9f1ca9100
728550ketoconazole 2 % Topical FoamPSN9b65f632-a98d-400e-9ec3-84dea581d6a38
728550ketoconazole 20 MG/ML Topical FoamSCD9b65f632-a98d-400e-9ec3-84dea581d6a38
728550ketoconazole 2 % Topical FoamSY9b65f632-a98d-400e-9ec3-84dea581d6a38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-532-32458020532321 CANISTER in 1 CARTON (45802-532-32) / 50 g in 1 CANISTER1 canister2011-08-300000-00-00NoNoCurrent
45802-532-33458020532331 CANISTER in 1 CARTON (45802-532-33) / 100 g in 1 CANISTER1 canister2011-08-300000-00-00NoNoCurrent