MICONAZOLE NITRATE

Product NDC
84387-003
11-digit product format
843870003
Labeler code
84387
Product ID
84387-003_26bc78a5-3755-5f69-e063-6394a90a11a8
Type
HUMAN OTC DRUG
Nonproprietary name
MICONAZOLE NITRATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
ALLIED TRADE LINK LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-25
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
MICONAZOLE NITRATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84387-003-01MICONAZOLE NITRATE28.4 g in 1 TUBEOINTMENT28.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84387-003MICONAZOLE NITRATE OINTMENT [ALLIED TRADE LINK LLC]2Current NDC, 1 package rows20241115_25520dba-0159-2a3f-e063-6294a90a4c33.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84387-003-018438700030128.4 g in 1 TUBE (84387-003-01) 28.4 g2024-10-25NoNoCurrent