MICONAZOLE Nitrate

Product NDC
68071-3429
11-digit product format
680713429
Labeler code
68071
Product ID
68071-3429_2d587184-fc1e-2fda-e063-6394a90a32fa
Type
HUMAN OTC DRUG
Nonproprietary name
MICONAZOLE NITRATE
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-03-22
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
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 NITRATE2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998483

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3429-32025-03-04C16284748780-12cef2736-672a-d83d-e063-dadaa90ab31fMICONAZOLE Nitrate 2% Cream ANTIFUNGAL
68071-3429-32025-01-30C16284748780-12cef2736-672a-d83d-e063-dadaa90ab31fMICONAZOLE Nitrate 2% Cream ANTIFUNGAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3429-3MICONAZOLE Nitrate30 g in 1 TUBECREAM302
68071-3429-3MICONAZOLE Nitrate1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3429MICONAZOLE NITRATE CREAM [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 2 package rows20250306_fd7dd2eb-03a7-ef1f-e053-6294a90a8557.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSNfd7dd2eb-03a7-ef1f-e053-6294a90a85572
998483miconazole nitrate 20 MG/ML Topical CreamSCDfd7dd2eb-03a7-ef1f-e053-6294a90a85572
998483miconazole nitrate 2 % Topical CreamSYfd7dd2eb-03a7-ef1f-e053-6294a90a85572

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3429-3680713429031 TUBE in 1 BOX (68071-3429-3) / 30 g in 1 TUBE1 tube2023-06-06NoNoCurrent