Econazole Nitrate

Product NDC
63629-8646
11-digit product format
636298646
Labeler code
63629
Product ID
63629-8646_2f1bd23c-d3ae-40cf-a8ec-4df1934b51fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Econazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
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
63629-8646-1Econazole Nitrate1 in 1 CARTONCREAM1105
63629-8646-1Econazole Nitrate30 g in 1 TUBECREAM30105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8646-1GM - Gram63629-86465417826a-67ef-4d6e-9f62-2e9dbb63970012021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8646ECONAZOLE NITRATE CREAM [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 2 package rows20240814_4ac65707-a8b2-45de-a3c6-89e3ea845124.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8646-1636298646011 TUBE in 1 CARTON (63629-8646-1) / 30 g in 1 TUBE1 tube2006-11-100000-00-00NoNoCurrent