Freds

Product NDC
55315-737
11-digit product format
553150737
Labeler code
55315
Product ID
55315-737_4c5dc483-ffb4-4a86-bdd1-dbfef0d41a26
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
FRED'S, INC.
Application
ANDA076773
Marketing category
ANDA
Marketing start
2005-03-02
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
40 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
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55315-737-432025-07-29C16284748780-13b156c62-2f1f-fb37-e063-e6dba90a4e07Fred's Miconazole 3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55315-737-43Freds Miconazole 325 g in 1 TUBE, WITH APPLICATORCREAM251
55315-737-43Freds Miconazole 31 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55315-737FREDS MICONAZOLE 3 (MICONAZOLE NITRATE) CREAM [FRED'S, INC.]1Legacy NDC, 2 package rows20190109_35bd36ef-1bf5-480c-9a5b-7faf4c935476.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998544miconazole nitrate 4 % Vaginal CreamPSN35bd36ef-1bf5-480c-9a5b-7faf4c9354761
998544miconazole nitrate 40 MG/ML Vaginal CreamSCD35bd36ef-1bf5-480c-9a5b-7faf4c9354761
998544miconazole nitrate 4 % Vaginal CreamSY35bd36ef-1bf5-480c-9a5b-7faf4c9354761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55315-737-43553150737431 TUBE, WITH APPLICATOR in 1 CARTON (55315-737-43) > 25 g in 1 TUBE, WITH APPLICATOR2018-12-200000-00-00NoNoCurrent