MICONAZOLE Nitrate 2% Cream ANTIFUNGAL

Product NDC
68788-8895
11-digit product format
687888895
Labeler code
68788
Product ID
68788-8895_cca84334-2e2d-4991-9d1e-d5b7c9ffd392
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
2025-08-01
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
68788-8895-3MICONAZOLE Nitrate 2% Cream ANTIFUNGAL28.3 g in 1 TUBECREAM28.31
68788-8895-3MICONAZOLE Nitrate 2% Cream ANTIFUNGAL1 in 1 BOXCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8895-3GM - Gram68788-88956081a260-03a0-4a4b-8f07-b41b567f169612025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
68788-8895-3687888895031 TUBE in 1 BOX (68788-8895-3) / 28.3 g in 1 TUBE1 tube2025-08-01NoNoCurrent