FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiH438WYN10E
Rxcui857366

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ECONAZOLE NITRATEACTIVE INGREDIENTH438WYN10EECONAZOLE NITRATE CREAM [PERRIGO NEW YORK INC]5
ECONAZOLEACTIVE MOIETY6Z1Y2V4A7MECONAZOLE NITRATE CREAM [PERRIGO NEW YORK INC]5
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMECONAZOLE NITRATE CREAM [PERRIGO NEW YORK INC]5
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UECONAZOLE NITRATE CREAM [PERRIGO NEW YORK INC]5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPECONAZOLE NITRATE CREAM [PERRIGO NEW YORK INC]5
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G50ECONAZOLE NITRATE CREAM [PERRIGO NEW YORK INC]5
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X5ECONAZOLE NITRATE CREAM [PERRIGO NEW YORK INC]5
WATERINACTIVE INGREDIENT059QF0KO0RECONAZOLE NITRATE CREAM [PERRIGO NEW YORK INC]5
ECONAZOLE NITRATEACTIVE INGREDIENTH438WYN10EECONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]1
ECONAZOLEACTIVE MOIETY6Z1Y2V4A7MECONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]1
benzoic acidINACTIVE INGREDIENT8SKN0B0MIMECONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UECONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPECONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RECONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]1

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

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