Econazole Nitrate

Product NDC
51672-1303
11-digit product format
516721303
Labeler code
51672
Product ID
51672-1303_3d47799f-26f4-68d6-e063-6294a90a4ab5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Econazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA076005
Marketing category
ANDA
Marketing start
2002-11-26
Substance
ECONAZOLE NITRATE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Econazole Nitrate
Listing expiration
2026-12-31

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
51672-1303-1Econazole Nitrate15 g in 1 TUBECREAM158
51672-1303-1Econazole Nitrate1 in 1 CARTONCREAM18
51672-1303-2Econazole Nitrate30 g in 1 TUBECREAM308
51672-1303-2Econazole Nitrate1 in 1 CARTONCREAM18
51672-1303-8Econazole Nitrate85 g in 1 TUBECREAM858
51672-1303-8Econazole Nitrate1 in 1 CARTONCREAM18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1303-1GM - Gram51672-13037c2f8038-50f5-484d-8a13-081c36b4b1e212013-02-13
51672-1303-2GM - Gram51672-130337ad2634-e132-4208-83fe-215a91fcb47712013-02-13
51672-1303-8GM - Gram51672-13035737f6b6-4d86-4315-a8e4-381f0486997312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Econazole NitrateACTIVE INGREDIENTH438WYN10EECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
EconazoleACTIVE MOIETY6Z1Y2V4A7MECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
apricot kernel oil PEG-6 estersINACTIVE INGREDIENTDRG3KJZ1TJECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
benzoic acidINACTIVE INGREDIENT8SKN0B0MIMECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
glycol stearateINACTIVE INGREDIENT0324G66D0EECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
mineral oilINACTIVE INGREDIENTT5L8T28FGPECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
PEG-32 stearateINACTIVE INGREDIENT33GX5WQC0MECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
PEG-6 stearateINACTIVE INGREDIENT8LQC57C6B0ECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
ECONAZOLE NITRATEACTIVE INGREDIENTH438WYN10EECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
ECONAZOLEACTIVE MOIETY6Z1Y2V4A7MECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
APRICOT KERNEL OIL PEG-6 ESTERSINACTIVE INGREDIENTDRG3KJZ1TJECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0EECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
PEG-32 STEARATEINACTIVE INGREDIENT33GX5WQC0MECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
PEG-6 STEARATEINACTIVE INGREDIENT8LQC57C6B0ECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1303ECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]6Current NDC, Legacy NDC, 6 package rows20241222_90c40d7f-94fa-440c-9815-30378f76ae79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857366econazole nitrate 1 % Topical CreamPSN90c40d7f-94fa-440c-9815-30378f76ae798
857366econazole nitrate 10 MG/ML Topical CreamSCD90c40d7f-94fa-440c-9815-30378f76ae798
857366econazole nitrate 1 % Topical CreamSY90c40d7f-94fa-440c-9815-30378f76ae798
857366econazole nitrate 10 MG per 1 GM Topical CreamSY90c40d7f-94fa-440c-9815-30378f76ae798
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
857366econazole nitrate 1 % Topical CreamPSN1d53c0f4-d94f-2691-e063-6394a90aa2011
857366econazole nitrate 1 % Topical CreamPSN842d29e0-b698-4353-b8ac-368b51b4ae851
857366econazole nitrate 10 MG/ML Topical CreamSCD1d53c0f4-d94f-2691-e063-6394a90aa2011
857366econazole nitrate 10 MG/ML Topical CreamSCD842d29e0-b698-4353-b8ac-368b51b4ae851
857366econazole nitrate 1 % Topical CreamSY1d53c0f4-d94f-2691-e063-6394a90aa2011
857366econazole nitrate 1 % Topical CreamSY842d29e0-b698-4353-b8ac-368b51b4ae851
857366econazole nitrate 10 MG per 1 GM Topical CreamSY1d53c0f4-d94f-2691-e063-6394a90aa2011
857366econazole nitrate 10 MG per 1 GM Topical CreamSY842d29e0-b698-4353-b8ac-368b51b4ae851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1303-1516721303011 TUBE in 1 CARTON (51672-1303-1) / 15 g in 1 TUBE1 tube2002-11-260000-00-00NoNoCurrent
51672-1303-2516721303021 TUBE in 1 CARTON (51672-1303-2) / 30 g in 1 TUBE1 tube2002-11-260000-00-00NoNoCurrent
51672-1303-8516721303081 TUBE in 1 CARTON (51672-1303-8) / 85 g in 1 TUBE1 tube2002-11-260000-00-00NoNoCurrent