Anti-fungal Powder Miconazole Nitrate

Product NDC
56104-500
11-digit product format
561040500
Labeler code
56104
Product ID
56104-500_42537026-f1f3-422f-e063-6394a90a07e9
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
2023-09-12
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
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
Anti-fungal Powder Miconazole Nitrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

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
56104-500-00Anti-fungal Powder Miconazole Nitrate71 g in 1 BOTTLE, PLASTICPOWDER714

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56104-500ANTI-FUNGAL POWDER MICONAZOLE NITRATE (MICONAZOLE NITRATE) POWDER [PREMIER BRANDS OF AMERICA INC.]3Current NDC, 1 package rows20241016_052d8d02-2381-1e3a-e063-6394a90aa07e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSN052d8d02-2381-1e3a-e063-6394a90aa07e4
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD052d8d02-2381-1e3a-e063-6394a90aa07e4
998461miconazole nitrate 2 % Topical PowderSY052d8d02-2381-1e3a-e063-6394a90aa07e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
56104-500-005610405000071 g in 1 BOTTLE, PLASTIC (56104-500-00) 71 g2023-09-12NoNoCurrent