VAGISTEN-V

Product NDC
69729-612
11-digit product format
697290612
Labeler code
69729
Product ID
69729-612_214e6edc-8028-e8d5-e063-6394a90af7a0
Type
HUMAN OTC DRUG
Nonproprietary name
MICONAZOLE NITRATE
Dosage form
CREAM
Route
VAGINAL
Labeler
OPMX LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-05
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VAGISTEN-V
Brand name suffix
7 DAY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998540

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
69729-612-052024-11-29C16284748780-19d75b9d0-0c4c-f424-e053-dadaa90a57ceOPMX (as PLD) - Vagisten-V (69729-612)
69729-612-052020-01-31C16284748780-19d75b9d0-0c4c-f424-e053-dadaa90a57ceOPMX (as PLD) - Vagisten-V (69729-612)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-612-01VAGISTEN-V7 DAY14 g in 1 TUBECREAM142
69729-612-05VAGISTEN-V7 DAY1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-612VAGISTEN-V 7 DAY (MICONAZOLE NITRATE) CREAM [OPMX LLC]2Current NDC, Legacy NDC, 2 package rows20241201_a5bfa501-5ae1-4434-bc31-995d0665b99e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998540miconazole nitrate 2 % Vaginal CreamPSNa5bfa501-5ae1-4434-bc31-995d0665b99e2
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDa5bfa501-5ae1-4434-bc31-995d0665b99e2
998540miconazole nitrate 2 % Vaginal CreamSYa5bfa501-5ae1-4434-bc31-995d0665b99e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69729-612-016972906120114 g in 1 TUBE14 gHistorical
69729-612-05697290612051 TUBE in 1 BOX (69729-612-05) / 14 g in 1 TUBE (69729-612-01) 1 tube2018-09-05NoNoCurrent