Miconazole Nitrate

Product NDC
42254-295
11-digit product format
422540295
Labeler code
42254
Product ID
42254-295_0e4c7ff6-7bea-4257-bd95-d4d5298ae426
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
SUPPOSITORY
Route
VAGINAL
Labeler
Rebel Distributors Corp
Application
ANDA074414
Marketing category
ANDA
Marketing start
1997-04-30
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
100 ug/1
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
42254-295-072019-09-24C16284748780-19350213a-3c50-c013-e053-90daa90a1393Miconazole Nitrate, Vaginal Suppositories USP, 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-295-07Miconazole Nitrate7 in 1 BOXSUPPOSITORY71

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-295-07EA - Each42254-295c5d44f30-1c71-48b9-892e-201cc456773912013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE NITRATE SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
MiconazoleACTIVE MOIETY7NNO0D7S5MMICONAZOLE NITRATE SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
Hydrogenated Coconut OilINACTIVE INGREDIENTJY81OXM1OMMICONAZOLE NITRATE SUPPOSITORY [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-295MICONAZOLE NITRATE SUPPOSITORY [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20130329_0e4c7ff6-7bea-4257-bd95-d4d5298ae426.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-295-07422540295077 in 1 BOXHistorical