FDA.reportPublic FDA data

Econazole Nitrate

Product NDC
52565-022
11-digit product format
525650022
Labeler code
52565
Product ID
52565-022_4fbee603-de52-4aec-b5eb-8cf29a8a01db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Econazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA076574
Marketing category
ANDA
Marketing start
2013-08-01
Marketing end
0000-00-00
Substance
ECONAZOLE NITRATE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC],Azoles [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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
52565-022-152023-01-30C16284748780-1f386c649-bb85-0266-e053-dadaa90a7c1aEconazole Nitrate Cream 1%
52565-022-302023-01-30C16284748780-1f386c649-bb85-0266-e053-dadaa90a7c1aEconazole Nitrate Cream 1%
52565-022-852023-01-30C16284748780-1f386c649-bb85-0266-e053-dadaa90a7c1aEconazole Nitrate Cream 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-022-15Econazole Nitrate1 in 1 CARTONCREAM16
52565-022-15Econazole Nitrate15 g in 1 TUBECREAM156
52565-022-30Econazole Nitrate30 g in 1 TUBECREAM306
52565-022-30Econazole Nitrate1 in 1 CARTONCREAM16
52565-022-85Econazole Nitrate85 g in 1 TUBECREAM856
52565-022-85Econazole Nitrate1 in 1 CARTONCREAM16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-022-15GM - Gram52565-022e59f81fc-edcb-42b9-afc2-4d6523ca44f512013-08-02
52565-022-30GM - Gram52565-022e1bc6e2b-0fad-4a0c-abc6-797cb1e5881212013-08-02
52565-022-85GM - Gram52565-02238cf1b76-c9ab-4ac9-9ec6-680759ae83e712013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Econazole NitrateACTIVE INGREDIENTH438WYN10EECONAZOLE NITRATE CREAM [IGI LABS, INC.]1
EconazoleACTIVE MOIETY6Z1Y2V4A7MECONAZOLE NITRATE CREAM [IGI LABS, INC.]1
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIMECONAZOLE NITRATE CREAM [IGI LABS, INC.]1
Butylated HydroxyanisoleINACTIVE INGREDIENTREK4960K2UECONAZOLE NITRATE CREAM [IGI LABS, INC.]1
Mineral OilINACTIVE INGREDIENTT5L8T28FGPECONAZOLE NITRATE CREAM [IGI LABS, INC.]1
PEG-5 OleateINACTIVE INGREDIENT0240V77G50ECONAZOLE NITRATE CREAM [IGI LABS, INC.]1
Pegoxol 7 StearateINACTIVE INGREDIENT3EW5AXE5X5ECONAZOLE NITRATE CREAM [IGI LABS, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RECONAZOLE NITRATE CREAM [IGI LABS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-022ECONAZOLE NITRATE CREAM [TELIGENT PHARMA, INC.]6Legacy NDC, 6 package rows20210918_51fd5746-8313-4f68-b929-8481ad8ca241.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857366econazole nitrate 1 % Topical CreamPSN51fd5746-8313-4f68-b929-8481ad8ca2416
857366econazole nitrate 10 MG/ML Topical CreamSCD51fd5746-8313-4f68-b929-8481ad8ca2416
857366econazole nitrate 1 % Topical CreamSY51fd5746-8313-4f68-b929-8481ad8ca2416
857366econazole nitrate 10 MG per 1 GM Topical CreamSY51fd5746-8313-4f68-b929-8481ad8ca2416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-022-15525650022151 TUBE in 1 CARTON (52565-022-15) > 15 g in 1 TUBE1 tube2013-08-010000-00-00NoNoCurrent
52565-022-30525650022301 TUBE in 1 CARTON (52565-022-30) > 30 g in 1 TUBE1 tube2013-08-010000-00-00NoNoCurrent
52565-022-85525650022851 TUBE in 1 CARTON (52565-022-85) > 85 g in 1 TUBE1 tube2013-08-010000-00-00NoNoCurrent