Econazole Nitrate

Product NDC
68788-8174
11-digit product format
687888174
Labeler code
68788
Product ID
68788-8174_406c3588-6206-4be4-a148-47e489feed8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Econazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA076005
Marketing category
ANDA
Marketing start
2022-04-27
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
68788-8174-1Econazole Nitrate1 in 1 CARTONCREAM15
68788-8174-1Econazole Nitrate15 g in 1 TUBECREAM155

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8174-1GM - Gram68788-8174537ae8fa-fe84-46bf-9e65-a390e12d37dc12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8174ECONAZOLE NITRATE CREAM [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20250409_6989d30f-9bb7-4e6e-92de-05e9f9a4f523.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857366econazole nitrate 1 % Topical CreamPSN6989d30f-9bb7-4e6e-92de-05e9f9a4f5235
857366econazole nitrate 10 MG/ML Topical CreamSCD6989d30f-9bb7-4e6e-92de-05e9f9a4f5235
857366econazole nitrate 1 % Topical CreamSY6989d30f-9bb7-4e6e-92de-05e9f9a4f5235
857366econazole nitrate 10 MG per 1 GM Topical CreamSY6989d30f-9bb7-4e6e-92de-05e9f9a4f5235

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8174-1687888174011 TUBE in 1 CARTON (68788-8174-1) / 15 g in 1 TUBE1 tube2022-04-270000-00-00NoNoCurrent