Miconazole nitrate

Product NDC
55681-165
11-digit product format
556810165
Labeler code
55681
Product ID
55681-165_e69cd379-fdb6-b737-e053-2995a90aba3e
Type
HUMAN OTC DRUG
Nonproprietary name
Antifungal
Dosage form
POWDER
Route
TOPICAL
Labeler
TWIN MED, LLC
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-08-19
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
55681-165-03Miconazole nitrate85 g in 1 BOTTLE, PLASTICPOWDER854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55681-165MICONAZOLE NITRATE (ANTIFUNGAL) POWDER [TWIN MED, LLC]3Legacy NDC, 1 package rows20240109_e69c8d1a-cf46-d3e1-e053-2995a90aaa75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSNe69c8d1a-cf46-d3e1-e053-2995a90aaa754
998461miconazole nitrate 0.02 MG/MG Topical PowderSCDe69c8d1a-cf46-d3e1-e053-2995a90aaa754
998461miconazole nitrate 2 % Topical PowderSYe69c8d1a-cf46-d3e1-e053-2995a90aaa754

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55681-165-035568101650385 g in 1 BOTTLE, PLASTIC (55681-165-03) 85 g2022-08-190000-00-00NoNoCurrent