miconazole nitrate

Product NDC
50268-503
11-digit product format
502680503
Labeler code
50268
Product ID
50268-503_47fa5320-5565-5626-e063-6394a90a4396
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
AvPAK
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-13
Substance
MICONAZOLE NITRATE
Active strength
20 mg/mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
miconazole nitrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998525

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-503-29miconazole nitrate29.57 mL in 1 BOTTLESOLUTION29.577

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-503-29ML - Milliliter50268-5034b779401-2bf7-4e25-aa07-f5c7dd11149412022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-503MICONAZOLE NITRATE SOLUTION [AVPAK]6Current NDC, Legacy NDC, 1 package rows20240308_eaf016f6-b631-af00-e053-2a95a90adc7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998525miconazole nitrate 2 % Topical SolutionPSNeaf016f6-b631-af00-e053-2a95a90adc7b7
998525miconazole nitrate 20 MG/ML Topical SolutionSCDeaf016f6-b631-af00-e053-2a95a90adc7b7
998525miconazole nitrate 2 % Topical SolutionSYeaf016f6-b631-af00-e053-2a95a90adc7b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-503-295026805032929.57 mL in 1 BOTTLE (50268-503-29) 29.57 ml2022-10-130000-00-00NoNoCurrent