ERTACZO

Product NDC
21695-454
11-digit product format
216950454
Labeler code
21695
Product ID
21695-454_430b8bbe-96e2-4300-af13-a0704ac11076
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ERTACZO
Dosage form
CREAM
Route
TOPICAL
Labeler
Rebel Distributors Corp.
Application
ANDA021385
Marketing category
ANDA
Marketing start
2003-12-10
Marketing end
0000-00-00
Substance
SERTACONAZOLE NITRATE
Active strength
20 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
09e0e2f9-42bd-4b8d-2b03-532b72ee76cfProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-454-302019-09-24C16284748780-1934fe258-4c38-48b1-e053-8cdaa90a720aERTACZO(sertaconazole nitrate) Cream, 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-454-30ERTACZO30 g in 1 TUBECREAM301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sertaconazole NitrateACTIVE INGREDIENT1DV05410M5ERTACZO CREAM [REBEL DISTRIBUTORS CORP.]1
SertaconazoleACTIVE MOIETY72W71I16EGERTACZO CREAM [REBEL DISTRIBUTORS CORP.]1
ETHYLENE GLYCOLINACTIVE INGREDIENTFC72KVT52FERTACZO CREAM [REBEL DISTRIBUTORS CORP.]1
Light mineral oilINACTIVE INGREDIENTN6K5787QVPERTACZO CREAM [REBEL DISTRIBUTORS CORP.]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TERTACZO CREAM [REBEL DISTRIBUTORS CORP.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AERTACZO CREAM [REBEL DISTRIBUTORS CORP.]1
Sorbic acidINACTIVE INGREDIENTX045WJ989BERTACZO CREAM [REBEL DISTRIBUTORS CORP.]1
WaterINACTIVE INGREDIENT059QF0KO0RERTACZO CREAM [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-454ERTACZO CREAM [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20091211_2e11cbfd-47c8-4d0f-ac7d-0beca0ea58aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
250511sertaconazole 2 % Topical CreamPSN2e11cbfd-47c8-4d0f-ac7d-0beca0ea58aa1
250511sertaconazole 20 MG/ML Topical CreamSCD2e11cbfd-47c8-4d0f-ac7d-0beca0ea58aa1
250511sertaconazole 2 % Topical CreamSY2e11cbfd-47c8-4d0f-ac7d-0beca0ea58aa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-454-302169504543030 g in 1 TUBE30 gHistorical