Novana Antifungal Barrier with Miconazole

Product NDC
76077-400
11-digit product format
760770400
Labeler code
76077
Product ID
76077-400_34463f8e-014f-4ad5-80b3-ad5542a541bd
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Novana Medical, LLC
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-04-04
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
0 mL/mL
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76077-400-042019-11-13C16284748780-197449f38-b840-f6ea-e053-dbdaa90aa703Drug Facts
76077-400-072019-11-13C16284748780-197449f38-b840-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76077-400-04Novana Antifungal Barrier with Miconazole120 mL in 1 TUBECREAM1203
76077-400-07Novana Antifungal Barrier with Miconazole210 mL in 1 TUBECREAM2103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76077-400NOVANA ANTIFUNGAL BARRIER WITH MICONAZOLE (MICONAZOLE NITRATE) CREAM [NOVANA MEDICAL, LLC]3Legacy NDC, 2 package rows20120426_164afeb1-d8b1-4b2c-8e07-c1a27550c5ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN164afeb1-d8b1-4b2c-8e07-c1a27550c5ad3
998483miconazole nitrate 20 MG/ML Topical CreamSCD164afeb1-d8b1-4b2c-8e07-c1a27550c5ad3
998483miconazole nitrate 2 % Topical CreamSY164afeb1-d8b1-4b2c-8e07-c1a27550c5ad3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
76077-400-0476077040004120 mL in 1 TUBE120 mlHistorical
76077-400-0776077040007210 mL in 1 TUBE210 mlHistorical