Econazole Nitrate

Product NDC
33261-956
11-digit product format
332610956
Labeler code
33261
Product ID
33261-956_210af85b-9e0f-4bd9-94f9-77ffe42b013f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Econazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076005
Marketing category
ANDA
Marketing start
2002-11-26
Marketing end
0000-00-00
Substance
ECONAZOLE NITRATE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC],Azoles [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33261-956IInactivated by FDA2026-08-17
excluded packagepackage33261-95633261-956-01IInactivated by FDA2026-08-17

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 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-956-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-956-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-956-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-956-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-956-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-956-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-956-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-956-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-956-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-956-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-956-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-956-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-956-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-956-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-956-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage33261-956-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage33261-956-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage33261-956-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage33261-956-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage33261-956-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage33261-956-019bebd1f3094a…5416666fcb17…

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
A076005-001ECONAZOLE NITRATEECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076005-001AB

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 06:07:402026-07A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-263f01610625f2…
2019-09-15 20:21 UTC2019-09A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076005-001ECONAZOLE NITRATE1%CREAM / TOPICALAB2002-11-26e64feba35796…

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 06:07:402026-07A076005-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076005-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076005-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076005-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076005-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076005-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076005-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076005-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076005-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076005-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076005-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076005-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076005-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076005-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076005-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076005-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076005-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076005-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076005-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076005-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076005-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076005-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076005-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076005-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076005-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076005-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076005-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076005-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076005-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076005-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076005-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076005-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076005-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076005-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076005-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076005-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076005-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076005-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076005-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076005-001AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
e3a04dc3-1a9e-4fba-b2b4-a18279351082Product name220180620
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
aa7deb41-117b-479c-8362-130fd1c222deProduct name120160112

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-956-012020-01-31C16284748780-19d75b9cf-f1fa-f424-e053-dadaa90a57ceEconazole Nitrate Cream 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-956-01Econazole Nitrate1 in 1 CARTONCREAM11
33261-956-01Econazole Nitrate15 g in 1 TUBECREAM151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-956-01GM - Gram33261-956e11f0db9-49fe-4c8c-bcdd-786b4c1ce8e712015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ECONAZOLE NITRATEACTIVE INGREDIENTH438WYN10EECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
ECONAZOLEACTIVE MOIETY6Z1Y2V4A7MECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
APRICOT KERNEL OIL PEG-6 ESTERSINACTIVE INGREDIENTDRG3KJZ1TJECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0EECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
PEG-32 STEARATEINACTIVE INGREDIENT33GX5WQC0MECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
PEG-6 STEARATEINACTIVE INGREDIENT8LQC57C6B0ECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-956ECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140107_842d29e0-b698-4353-b8ac-368b51b4ae85.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Econazole NitrateECONAZOLE NITRATEPreferred Pharmaceuticals Inc.6989d30f-9bb7-4e6e-92de-05e9f9a4f5232026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076005
application number: ANDA076005
Econazole NitrateECONAZOLE NITRATESun Pharmaceutical Industries, Inc.90c40d7f-94fa-440c-9815-30378f76ae792025-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076005
application number: ANDA076005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857366econazole nitrate 1 % Topical CreamPSN842d29e0-b698-4353-b8ac-368b51b4ae851
857366econazole nitrate 10 MG/ML Topical CreamSCD842d29e0-b698-4353-b8ac-368b51b4ae851
857366econazole nitrate 1 % Topical CreamSY842d29e0-b698-4353-b8ac-368b51b4ae851
857366econazole nitrate 10 MG per 1 GM Topical CreamSY842d29e0-b698-4353-b8ac-368b51b4ae851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-956-01332610956011 in 1 CARTONHistorical