FDA.reportPublic FDA data

MICONAZOLE Nitrate 2% Cream ANTIFUNGAL

Product NDC
68788-8845
11-digit product format
687888845
Labeler code
68788
Product ID
68788-8845_14d2a661-a490-41ca-b84f-f2be3bc271b4
Type
HUMAN OTC DRUG
Nonproprietary name
MICONAZOLE NITRATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-24
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
68788-8845-3MICONAZOLE Nitrate 2% Cream ANTIFUNGAL30 g in 1 TUBECREAM301
68788-8845-3MICONAZOLE Nitrate 2% Cream ANTIFUNGAL1 in 1 BOXCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8845-3GM - Gram68788-88450a9b250c-7f23-4682-af64-35497e19150912025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8845MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20250326_14d2a661-a490-41ca-b84f-f2be3bc271b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN14d2a661-a490-41ca-b84f-f2be3bc271b41
998483miconazole nitrate 20 MG/ML Topical CreamSCD14d2a661-a490-41ca-b84f-f2be3bc271b41
998483miconazole nitrate 2 % Topical CreamSY14d2a661-a490-41ca-b84f-f2be3bc271b41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8845-3687888845031 TUBE in 1 BOX (68788-8845-3) / 30 g in 1 TUBE1 tube2025-03-24NoNoHistorical