Anti- Fungal Miconazole Nitrate

Product NDC
56104-253
11-digit product format
561040253
Labeler code
56104
Product ID
56104-253_3bba5b9f-d184-6f93-e063-6394a90ae951
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
POWDER
Route
TOPICAL
Labeler
Premier Brands of America Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-11
Marketing end
2027-01-31
Substance
MICONAZOLE NITRATE
Active strength
1.42 g/71g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Anti- Fungal Miconazole Nitrate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE1.42 g/71g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998461

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
56104-253-01Anti- Fungal Miconazole Nitrate71 g in 1 BOTTLE, PLASTICPOWDER717

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56104-253ANTI- FUNGAL MICONAZOLE NITRATE (MICONAZOLE NITRATE) POWDER [PREMIER BRANDS OF AMERICA INC.]6Current NDC, Legacy NDC, 1 package rows20241016_f186bdc1-db6c-0fab-e053-2995a90a7c58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSNf186bdc1-db6c-0fab-e053-2995a90a7c587
998461miconazole nitrate 0.02 MG/MG Topical PowderSCDf186bdc1-db6c-0fab-e053-2995a90a7c587
998461miconazole nitrate 2 % Topical PowderSYf186bdc1-db6c-0fab-e053-2995a90a7c587

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56104-253-015610402530171 g in 1 BOTTLE, PLASTIC (56104-253-01) 71 g2023-01-052027-01-31NoNoCurrent