Econazole Nitrate

Product NDC
45802-466
11-digit product format
458020466
Labeler code
45802
Product ID
45802-466_a926c9d7-1215-47b9-a0ed-462941c209fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Econazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA076479
Marketing category
ANDA
Marketing start
2006-08-08
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
A076479-001ECONAZOLE NITRATEECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076479-001AB

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 06:07:402026-07A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-233f01610625f2…
2019-09-15 20:21 UTC2019-09A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076479-001ECONAZOLE NITRATE1%CREAM / TOPICALABRS2004-06-23e64feba35796…

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 06:07:402026-07A076479-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076479-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076479-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076479-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076479-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076479-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076479-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076479-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076479-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076479-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076479-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076479-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076479-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076479-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076479-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076479-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076479-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076479-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076479-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076479-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076479-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076479-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076479-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076479-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076479-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076479-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076479-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076479-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076479-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076479-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076479-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076479-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076479-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076479-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076479-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076479-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076479-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076479-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076479-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076479-001AB1e64feba35796…

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
857366Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3acc5e03-0339-4b23-945d-641746e81923Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-466-11Econazole Nitrate1 in 1 CARTONCREAM110
45802-466-11Econazole Nitrate30 g in 1 TUBECREAM3010
45802-466-35Econazole Nitrate1 in 1 CARTONCREAM110
45802-466-35Econazole Nitrate15 g in 1 TUBECREAM1510
45802-466-53Econazole Nitrate1 in 1 CARTONCREAM110
45802-466-53Econazole Nitrate85 g in 1 TUBECREAM8510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-466-11GM - Gram45802-46695bd2a8b-e584-481c-9831-8ebac886cdae12012-07-24
45802-466-35GM - Gram45802-4662f3a93a0-9d26-450b-96a6-1ff122efadf412012-07-24
45802-466-53GM - Gram45802-466a9794e09-25cb-4232-9f03-6661db75afdb12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-466ECONAZOLE NITRATE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]10Current NDC, Legacy NDC, 6 package rows20240308_3acc5e03-0339-4b23-945d-641746e81923.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
Econazole NitrateECONAZOLE NITRATEBryant Ranch Prepack790a86cc-e93b-4bb6-9b60-08b2c45870812026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076479
application number: ANDA076479
Econazole NitrateECONAZOLE NITRATEPreferred Pharmaceuticals Inc.caa348ad-4832-435f-844d-55831f235cc02026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076479
application number: ANDA076479
Econazole NitrateECONAZOLE NITRATEPreferred Pharmaceuticals Inc.2bd2a48e-cbef-4b14-a02f-9aa693cc4b472025-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076479
application number: ANDA076479
Econazole NitrateECONAZOLE NITRATEBryant Ranch Prepackb0c90efd-d9a2-4120-aa17-33a9d50f73472025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076479
application number: ANDA076479
Econazole NitrateECONAZOLE NITRATEBryant Ranch Prepackae173340-7611-4dc8-99a7-7669bc4fc97d2024-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076479
application number: ANDA076479
Econazole NitrateECONAZOLE NITRATEBryant Ranch Prepack4ac65707-a8b2-45de-a3c6-89e3ea8451242024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076479
application number: ANDA076479
Econazole NitrateECONAZOLE NITRATEPadagis Israel Pharmaceuticals Ltd3acc5e03-0339-4b23-945d-641746e819232023-11-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076479
application number: ANDA076479
ndc (product): 45802-466

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857366econazole nitrate 1 % Topical CreamPSNb0c90efd-d9a2-4120-aa17-33a9d50f7347106
857366econazole nitrate 1 % Topical CreamPSNae173340-7611-4dc8-99a7-7669bc4fc97d106
857366econazole nitrate 10 MG/ML Topical CreamSCDb0c90efd-d9a2-4120-aa17-33a9d50f7347106
857366econazole nitrate 10 MG/ML Topical CreamSCDae173340-7611-4dc8-99a7-7669bc4fc97d106
857366econazole nitrate 1 % Topical CreamSYb0c90efd-d9a2-4120-aa17-33a9d50f7347106
857366econazole nitrate 1 % Topical CreamSYae173340-7611-4dc8-99a7-7669bc4fc97d106
857366econazole nitrate 10 MG per 1 GM Topical CreamSYb0c90efd-d9a2-4120-aa17-33a9d50f7347106
857366econazole nitrate 10 MG per 1 GM Topical CreamSYae173340-7611-4dc8-99a7-7669bc4fc97d106
857366econazole nitrate 1 % Topical CreamPSN4ac65707-a8b2-45de-a3c6-89e3ea845124105
857366econazole nitrate 10 MG/ML Topical CreamSCD4ac65707-a8b2-45de-a3c6-89e3ea845124105
857366econazole nitrate 1 % Topical CreamSY4ac65707-a8b2-45de-a3c6-89e3ea845124105
857366econazole nitrate 10 MG per 1 GM Topical CreamSY4ac65707-a8b2-45de-a3c6-89e3ea845124105
857366econazole nitrate 1 % Topical CreamPSN790a86cc-e93b-4bb6-9b60-08b2c4587081102
857366econazole nitrate 10 MG/ML Topical CreamSCD790a86cc-e93b-4bb6-9b60-08b2c4587081102
857366econazole nitrate 1 % Topical CreamSY790a86cc-e93b-4bb6-9b60-08b2c4587081102
857366econazole nitrate 10 MG per 1 GM Topical CreamSY790a86cc-e93b-4bb6-9b60-08b2c4587081102
857366econazole nitrate 1 % Topical CreamPSN3acc5e03-0339-4b23-945d-641746e8192310
857366econazole nitrate 10 MG/ML Topical CreamSCD3acc5e03-0339-4b23-945d-641746e8192310
857366econazole nitrate 1 % Topical CreamSY3acc5e03-0339-4b23-945d-641746e8192310
857366econazole nitrate 10 MG per 1 GM Topical CreamSY3acc5e03-0339-4b23-945d-641746e8192310
857366econazole nitrate 1 % Topical CreamPSNcaa348ad-4832-435f-844d-55831f235cc06
857366econazole nitrate 10 MG/ML Topical CreamSCDcaa348ad-4832-435f-844d-55831f235cc06
857366econazole nitrate 1 % Topical CreamSYcaa348ad-4832-435f-844d-55831f235cc06
857366econazole nitrate 10 MG per 1 GM Topical CreamSYcaa348ad-4832-435f-844d-55831f235cc06
857366econazole nitrate 1 % Topical CreamPSN2bd2a48e-cbef-4b14-a02f-9aa693cc4b471
857366econazole nitrate 1 % Topical CreamPSN28e567ca-dd90-45cc-894c-3304374975311
857366econazole nitrate 1 % Topical CreamPSN1c064402-022a-5bb4-e063-6294a90a0bcf1
857366econazole nitrate 10 MG/ML Topical CreamSCD2bd2a48e-cbef-4b14-a02f-9aa693cc4b471
857366econazole nitrate 10 MG/ML Topical CreamSCD28e567ca-dd90-45cc-894c-3304374975311
857366econazole nitrate 10 MG/ML Topical CreamSCD1c064402-022a-5bb4-e063-6294a90a0bcf1
857366econazole nitrate 1 % Topical CreamSY2bd2a48e-cbef-4b14-a02f-9aa693cc4b471
857366econazole nitrate 1 % Topical CreamSY28e567ca-dd90-45cc-894c-3304374975311
857366econazole nitrate 1 % Topical CreamSY1c064402-022a-5bb4-e063-6294a90a0bcf1
857366econazole nitrate 10 MG per 1 GM Topical CreamSY2bd2a48e-cbef-4b14-a02f-9aa693cc4b471
857366econazole nitrate 10 MG per 1 GM Topical CreamSY28e567ca-dd90-45cc-894c-3304374975311
857366econazole nitrate 10 MG per 1 GM Topical CreamSY1c064402-022a-5bb4-e063-6294a90a0bcf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-466-11458020466111 TUBE in 1 CARTON (45802-466-11) / 30 g in 1 TUBE1 tube2006-11-100000-00-00NoNoCurrent
45802-466-35458020466351 TUBE in 1 CARTON (45802-466-35) / 15 g in 1 TUBE1 tube2006-12-210000-00-00NoNoCurrent
45802-466-53458020466531 TUBE in 1 CARTON (45802-466-53) / 85 g in 1 TUBE1 tube2006-08-080000-00-00NoNoCurrent