Econazole Nitrate

Product NDC
73352-100
11-digit product format
733520100
Labeler code
73352
Product ID
73352-100_42777ef5-48c3-181e-e063-6394a90abce3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
econazole nitrate
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Trifluent Pharma, LLC
Application
NDA205175
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-09-13
Substance
ECONAZOLE NITRATE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
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
N205175-001ECOZAECONAZOLE NITRATE1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N205175-001100710542031-08-08Drug product2018-09-27

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 06:07:402026-07N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-2487673890dc5c…
2021-03-12 10:30 UTC2021-03N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-243f01610625f2…
2019-09-15 20:21 UTC2019-09N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24b00525d2431f…
2019-07-19 19:46 UTC2019-07N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-243f0d92c62455…
2023-05-13 08:27 UTC2023-05N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24053a50430f4f…
2023-01-26 05:58 UTC2023-01N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N205175-001ECOZA1%AEROSOL, FOAM / TOPICALRLD, RS2013-10-24e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N205175-001100710542031-08-08Drug product2018-09-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205175-001100710542031-08-08Drug product2018-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205175-001100710542031-08-08Drug product2018-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N205175-001100710542031-08-08Drug product2018-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205175-001100710542031-08-08Drug product2018-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205175-001100710542031-08-08Drug product2018-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205175-001100710542031-08-08Drug product2018-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205175-001100710542031-08-08Drug product2018-09-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205175-001100710542031-08-08Drug product2018-09-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205175-001100710542031-08-08Drug product2018-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205175-001100710542031-08-08Drug product2018-09-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205175-001100710542031-08-08Drug product2018-09-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205175-001100710542031-08-08Drug product2018-09-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205175-001100710542031-08-08Drug product2018-09-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205175-001100710542031-08-08Drug product2018-09-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205175-001100710542031-08-08Drug product2018-09-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205175-001100710542031-08-08Drug product2018-09-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205175-001100710542031-08-08Drug product2018-09-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205175-001100710542031-08-08Drug product2018-09-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N205175-001100710542031-08-08Drug product2018-09-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N205175-001100710542031-08-08Drug product2018-09-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205175-001100710542031-08-08Drug product2018-09-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N205175-001100710542031-08-08Drug product2018-09-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205175-001100710542031-08-08Drug product2018-09-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205175-001100710542031-08-08Drug product2018-09-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205175-001100710542031-08-08Drug product2018-09-273f01610625f2…
2019-09-15 20:21 UTC2019-09N205175-001100710542031-08-08Drug product2018-09-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N205175-001100710542031-08-08Drug product2018-09-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205175-001100710542031-08-08Drug product2018-09-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205175-001100710542031-08-08Drug product2018-09-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205175-001100710542031-08-08Drug product2018-09-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205175-001100710542031-08-08Drug product2018-09-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205175-001100710542031-08-08Drug product2018-09-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205175-001100710542031-08-08Drug product2018-09-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205175-001100710542031-08-08Drug product2018-09-273f0d92c62455…
2023-05-13 08:27 UTC2023-05N205175-001100710542031-08-08Drug product2018-09-27053a50430f4f…
2023-01-26 05:58 UTC2023-01N205175-001100710542031-08-08Drug product2018-09-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N205175-001100710542031-08-08Drug product2018-09-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N205175-001100710542031-08-08Drug product2018-09-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N205175-001100710542031-08-08Drug product2018-09-27e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ECONAZOLE NITRATE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H438WYN10EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1442585Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3eb40c94-f369-ce4b-e063-6294a90abed4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e3a04dc3-1a9e-4fba-b2b4-a18279351082Product name220180620
aa7deb41-117b-479c-8362-130fd1c222deProduct name120160112

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73352-100-70Econazole Nitrate1 in 1 CARTONAEROSOL, FOAM12
73352-100-70Econazole Nitrate70 g in 1 CANISTERAEROSOL, FOAM702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73352-100-70GM - Gram73352-100dd7ed98a-14cb-405f-ba84-90e6993f7e3112025-10-14

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 NITRATETrifluent Pharma, LLC3eb40c94-f369-ce4b-e063-6294a90abed42025-10-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 205175
application number: NDA205175
ndc (product): 73352-100
EcozaECONAZOLE NITRATEResilia Pharmaceuticals, Inc.0bb5fa27-32ed-ed13-e063-6394a90a15772023-12-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 205175
application number: NDA205175

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1442585econazole nitrate 1 % Topical FoamPSN3eb40c94-f369-ce4b-e063-6294a90abed42
1442585econazole nitrate 10 MG/ML Topical FoamSCD3eb40c94-f369-ce4b-e063-6294a90abed42
1442585econazole nitrate 1 % Topical FoamSY3eb40c94-f369-ce4b-e063-6294a90abed42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73352-100-70733520100701 CANISTER in 1 CARTON (73352-100-70) / 70 g in 1 CANISTER1 canister2025-09-13NoNoCurrent