FDA.reportPublic FDA data

Miconazole 1 Combination Pack

Product NDC
51316-005
11-digit product format
513160005
Labeler code
51316
Product ID
51316-005_ceb2e359-e195-4a2c-82ea-9dd13cebcbeb
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
KIT
Labeler
CVS PHARMACY, INC
Application
NDA020670
Marketing category
NDA
Marketing start
2022-01-30
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Miconazole 1 Combination Pack
Listing expiration
2027-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui992774, 992775, 998540

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
51316-005-012023-01-30C16284748780-1f386c64a-3016-0266-e053-dadaa90a7c1aMiconazole 1 Combination Pack

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-005-01Miconazole 1 Combination Pack1 in 1 PACKAGE, COMBINATIONKIT12
51316-090-01Miconazole 1 Combination Pack1 in 1 POUCHSUPPOSITORY11200 mg2
51316-091-01Miconazole 1 Combination Pack9 g in 1 TUBECREAM9 g20 mg in 1g2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-005MICONAZOLE 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CVS PHARMACY, INC]1Current NDC, Legacy NDC, 3 package rows20220130_4cbf37d1-023d-496f-84c8-a1b2a83a10ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992775{1 (miconazole nitrate 1200 MG Vaginal Insert) / 1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) } PackGPCK4cbf37d1-023d-496f-84c8-a1b2a83a10ef2
992775miconazole 1 day - (1200 MG insert / 2 % cream 9 GM) PackPSN4cbf37d1-023d-496f-84c8-a1b2a83a10ef2
992774miconazole nitrate 1200 MG Vaginal InsertPSN4cbf37d1-023d-496f-84c8-a1b2a83a10ef2
998540miconazole nitrate 2 % Vaginal CreamPSN4cbf37d1-023d-496f-84c8-a1b2a83a10ef2
992774miconazole nitrate 1200 MG Vaginal InsertSCD4cbf37d1-023d-496f-84c8-a1b2a83a10ef2
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD4cbf37d1-023d-496f-84c8-a1b2a83a10ef2
992774miconazole nitrate 1.2 GM Vaginal InsertSY4cbf37d1-023d-496f-84c8-a1b2a83a10ef2
998540miconazole nitrate 2 % Vaginal CreamSY4cbf37d1-023d-496f-84c8-a1b2a83a10ef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-005-01513160005011 KIT in 1 PACKAGE, COMBINATION (51316-005-01) * 9 g in 1 TUBE (51316-091-01) * 1 SUPPOSITORY in 1 POUCH (51316-090-01) 1 kit2022-01-300000-00-00NoNoCurrent
51316-090-01513160090011 in 1 POUCHHistorical
51316-091-01513160091019 g in 1 TUBE9 gHistorical