FDA.reportPublic FDA data

ECONAZOLE NITRATE

Product NDC
59651-945
11-digit product format
596510945
Labeler code
59651
Product ID
59651-945_5773bc55-511b-4168-a917-7c1f69e0853e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ECONAZOLE NITRATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Aurobindo Pharma Limited
Application
ANDA210364
Marketing category
ANDA
Marketing start
2026-03-13
Substance
ECONAZOLE NITRATE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ECONAZOLE NITRATE
Listing expiration
2027-12-31

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
59651-945-14ECONAZOLE NITRATE1 in 1 CARTONCREAM12
59651-945-14ECONAZOLE NITRATE15 g in 1 TUBECREAM152
59651-945-30ECONAZOLE NITRATE30 g in 1 TUBECREAM302
59651-945-30ECONAZOLE NITRATE1 in 1 CARTONCREAM12
59651-945-85ECONAZOLE NITRATE85 g in 1 TUBECREAM852
59651-945-85ECONAZOLE NITRATE1 in 1 CARTONCREAM12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857366econazole nitrate 1 % Topical CreamPSN74e5bbc9-eaea-405e-b64b-b3527c5ea0842
857366econazole nitrate 10 MG/ML Topical CreamSCD74e5bbc9-eaea-405e-b64b-b3527c5ea0842
857366econazole nitrate 1 % Topical CreamSY74e5bbc9-eaea-405e-b64b-b3527c5ea0842
857366econazole nitrate 10 MG per 1 GM Topical CreamSY74e5bbc9-eaea-405e-b64b-b3527c5ea0842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-945-14596510945141 TUBE in 1 CARTON (59651-945-14) / 15 g in 1 TUBE1 tube2026-03-13NoNoHistorical
59651-945-30596510945301 TUBE in 1 CARTON (59651-945-30) / 30 g in 1 TUBE1 tube2026-03-13NoNoHistorical
59651-945-85596510945851 TUBE in 1 CARTON (59651-945-85) / 85 g in 1 TUBE1 tube2026-03-13NoNoHistorical