Miconazole Nitrate

Product NDC
76413-318
11-digit product format
764130318
Labeler code
76413
Product ID
76413-318_6f218797-be08-4b07-8c82-21e2b57f0eb1
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
Central Texas Community Health Centers
Application
ANDA074366
Marketing category
ANDA
Marketing start
1996-02-22
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76413-318-452020-01-31C16284748780-19d75b9d1-2637-f424-e053-dadaa90a57ceMiconazole nitrate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-318-45Miconazole Nitrate45 g in 1 TUBE, WITH APPLICATORCREAM451
76413-318-45Miconazole Nitrate1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-318MICONAZOLE NITRATE (MICONAZOLE NITRATE) CREAM [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]1Legacy NDC, 2 package rows20160422_0878a5d4-d6c7-4e66-8956-9bd1acd9dfd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998540miconazole nitrate 2 % Vaginal CreamPSN0878a5d4-d6c7-4e66-8956-9bd1acd9dfd41
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD0878a5d4-d6c7-4e66-8956-9bd1acd9dfd41
998540miconazole nitrate 2 % Vaginal CreamSY0878a5d4-d6c7-4e66-8956-9bd1acd9dfd41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
76413-318-457641303184545 g in 1 TUBE, WITH APPLICATOR45 gHistorical