Miconazole Nitrate

Product NDC
55315-815
11-digit product format
553150815
Labeler code
55315
Product ID
55315-815_a97a84b3-99ed-4470-91f0-dc519360d24f
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
FRED'S, INC.
Application
ANDA074444
Marketing category
ANDA
Marketing start
1997-01-13
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
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
55315-815-632025-07-29C16284748780-13b156c62-270f-fb37-e063-e6dba90a4e07Miconazole Nitrate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55315-815-63Miconazole Nitrate45 g in 1 TUBE, WITH APPLICATORCREAM451
55315-815-63Miconazole Nitrate1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55315-815MICONAZOLE NITRATE CREAM [FRED'S, INC.]1Legacy NDC, 2 package rows20190221_d91714a5-20a6-4f0b-ba97-5c9e5f0dfc22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998540miconazole nitrate 2 % Vaginal CreamPSNd91714a5-20a6-4f0b-ba97-5c9e5f0dfc221
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDd91714a5-20a6-4f0b-ba97-5c9e5f0dfc221
998540miconazole nitrate 2 % Vaginal CreamSYd91714a5-20a6-4f0b-ba97-5c9e5f0dfc221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55315-815-63553150815631 TUBE, WITH APPLICATOR in 1 CARTON (55315-815-63) > 45 g in 1 TUBE, WITH APPLICATOR2019-02-140000-00-00NoNoCurrent