FDA.reportPublic FDA data

Econazole Nitrate

Product NDC
21695-892
11-digit product format
216950892
Labeler code
21695
Product ID
21695-892_28e567ca-dd90-45cc-894c-330437497531
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Econazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
ANDA076479
Marketing category
ANDA
Marketing start
2004-06-23
Marketing end
0000-00-00
Substance
ECONAZOLE NITRATE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC],Azoles [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-892-152019-09-24C16284748780-1934fe258-4bc9-48b1-e053-8cdaa90a720aEconazole Nitrate Cream, 1%
21695-892-302019-09-24C16284748780-1934fe258-4bc9-48b1-e053-8cdaa90a720aEconazole Nitrate Cream, 1%
21695-892-852019-09-24C16284748780-1934fe258-4bc9-48b1-e053-8cdaa90a720aEconazole Nitrate Cream, 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-892-15Econazole Nitrate15 g in 1 TUBECREAM151
21695-892-30Econazole Nitrate30 g in 1 TUBECREAM301
21695-892-85Econazole Nitrate85 g in 1 TUBECREAM851

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-892-15GM - Gram21695-89278917f2d-f0cc-41c4-a3bf-0ed845997c0712012-07-24
21695-892-30GM - Gram21695-8925ac57888-2353-4e56-b4a6-eb630b1c4c4c12012-07-24
21695-892-85GM - Gram21695-8926b1e09d1-fc40-440e-8b2c-8e398e63447d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
21695-892ECONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]1Legacy NDC, 3 package rows20110103_28e567ca-dd90-45cc-894c-330437497531.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857366econazole nitrate 1 % Topical CreamPSN28e567ca-dd90-45cc-894c-3304374975311
857366econazole nitrate 10 MG/ML Topical CreamSCD28e567ca-dd90-45cc-894c-3304374975311
857366econazole nitrate 1 % Topical CreamSY28e567ca-dd90-45cc-894c-3304374975311
857366econazole nitrate 10 MG per 1 GM Topical CreamSY28e567ca-dd90-45cc-894c-3304374975311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-892-152169508921515 g in 1 TUBE15 gHistorical
21695-892-302169508923030 g in 1 TUBE30 gHistorical
21695-892-852169508928585 g in 1 TUBE85 gHistorical