Premier Value

Product NDC
68016-070
11-digit product format
680160070
Labeler code
68016
Product ID
68016-070_b4cb8843-8811-4d06-989c-8aceeff009b7
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
Pharmacy Value Alliance LLC
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
68016-070-092025-07-29C16284748780-13b156c62-3371-fb37-e063-e6dba90a4e07Premier Value ® Miconazole 3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-070-09Premier Value Miconazole 31 in 1 CARTONCREAM13
68016-070-09Premier Value Miconazole 325 g in 1 TUBE, WITH APPLICATORCREAM253

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-070PREMIER VALUE MICONAZOLE 3 (MICONAZOLE NITRATE) CREAM [PHARMACY VALUE ALLIANCE LLC]3Legacy NDC, 2 package rows20170615_4c326c90-97a3-4c57-ac92-6621b8895c8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998544miconazole nitrate 4 % Vaginal CreamPSN4c326c90-97a3-4c57-ac92-6621b8895c8e3
998544miconazole nitrate 40 MG/ML Vaginal CreamSCD4c326c90-97a3-4c57-ac92-6621b8895c8e3
998544miconazole nitrate 4 % Vaginal CreamSY4c326c90-97a3-4c57-ac92-6621b8895c8e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68016-070-09680160070091 TUBE, WITH APPLICATOR in 1 CARTON (68016-070-09) > 25 g in 1 TUBE, WITH APPLICATOR2005-03-020000-00-00NoNoCurrent