Econazole Nitrate

Product NDC
63629-8647
11-digit product format
636298647
Labeler code
63629
Product ID
63629-8647_e55d252a-ff23-4fe5-b884-2dc696ffb7be
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
63629-8647-1Econazole Nitrate85 g in 1 TUBECREAM85106
63629-8647-1Econazole Nitrate1 in 1 CARTONCREAM1106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8647-1GM - Gram63629-8647ac5eef66-6753-4fbc-a603-ed7d9d15a14912023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8647ECONAZOLE NITRATE CREAM [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 2 package rows20250305_ae173340-7611-4dc8-99a7-7669bc4fc97d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857366econazole nitrate 1 % Topical CreamPSNae173340-7611-4dc8-99a7-7669bc4fc97d106
857366econazole nitrate 10 MG/ML Topical CreamSCDae173340-7611-4dc8-99a7-7669bc4fc97d106
857366econazole nitrate 1 % Topical CreamSYae173340-7611-4dc8-99a7-7669bc4fc97d106
857366econazole nitrate 10 MG per 1 GM Topical CreamSYae173340-7611-4dc8-99a7-7669bc4fc97d106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8647-1636298647011 TUBE in 1 CARTON (63629-8647-1) / 85 g in 1 TUBE1 tube2006-08-080000-00-00NoNoCurrent