MICONAZOLE Nitrate 2% Cream ANTIFUNGAL

Product NDC
0536-1375
11-digit product format
005361375
Labeler code
0536
Product ID
0536-1375_297d80f9-921c-0850-e063-6294a90a721a
Type
HUMAN OTC DRUG
Nonproprietary name
MICONAZOLE NITRATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Rugby
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-07
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
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
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998483

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1375-75MICONAZOLE Nitrate 2% Cream ANTIFUNGAL1 in 1 BOXCREAM12
0536-1375-75MICONAZOLE Nitrate 2% Cream ANTIFUNGAL28.3 g in 1 TUBECREAM28.32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1375-75GM - Gram0536-13754146e11a-5606-4fc8-a00f-0e0fcd2a9f4d12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1375MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [RUGBY]2Current NDC, 2 package rows20241220_f420de00-408f-9a2c-e053-2995a90adced.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSNf420de00-408f-9a2c-e053-2995a90adced2
998483miconazole nitrate 20 MG/ML Topical CreamSCDf420de00-408f-9a2c-e053-2995a90adced2
998483miconazole nitrate 2 % Topical CreamSYf420de00-408f-9a2c-e053-2995a90adced2
998483miconazole nitrate 2 % Topical CreamPSNcca84334-2e2d-4991-9d1e-d5b7c9ffd3921
998483miconazole nitrate 20 MG/ML Topical CreamSCDcca84334-2e2d-4991-9d1e-d5b7c9ffd3921
998483miconazole nitrate 2 % Topical CreamSYcca84334-2e2d-4991-9d1e-d5b7c9ffd3921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0536-1375-75005361375751 TUBE in 1 BOX (0536-1375-75) / 28.3 g in 1 TUBE1 tube2023-02-07NoNoHistorical