Miconazole 7

Product NDC
68071-2419
11-digit product format
680712419
Labeler code
68071
Product ID
68071-2419_c33f87bb-ac60-88da-e053-2995a90a92e1
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA074164
Marketing category
ANDA
Marketing start
2021-04-12
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
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
68071-2419-72025-01-30C16284748780-1f386c649-d51f-0266-e053-dadaa90a7c1aMiconazole 7
68071-2419-72023-10-05C16284748780-1f386c649-d51f-0266-e053-dadaa90a7c1aMiconazole 7
68071-2419-72023-01-30C16284748780-1f386c649-d51f-0266-e053-dadaa90a7c1aMiconazole 7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2419-7Miconazole 71 in 1 CARTONCREAM12
68071-2419-7Miconazole 745 g in 1 TUBE, WITH APPLICATORCREAM452

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2419MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20231006_c33f7d75-d976-7f46-e053-2a95a90a98ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998540miconazole nitrate 2 % Vaginal CreamPSNc33f7d75-d976-7f46-e053-2a95a90a98ec2
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDc33f7d75-d976-7f46-e053-2a95a90a98ec2
998540miconazole nitrate 2 % Vaginal CreamSYc33f7d75-d976-7f46-e053-2a95a90a98ec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2419-7680712419071 TUBE, WITH APPLICATOR in 1 CARTON (68071-2419-7) > 45 g in 1 TUBE, WITH APPLICATOR2021-05-260000-00-00NoNoCurrent