Quality Choice

Product NDC
63868-197
11-digit product format
638680197
Labeler code
63868
Product ID
63868-197_8d8b54e5-1580-48a3-bb39-8e3e61a4e68f
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
Chain Drug Marketing Association
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
2019-12-31
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
63868-197-252020-01-31C16284748780-19d75b9d0-b422-f424-e053-dadaa90a57ceQuality Choice ® 3 Day Vaginal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-197-25Quality Choice 3 Day Vaginal1 in 1 CARTONCREAM11
63868-197-25Quality Choice 3 Day Vaginal25 g in 1 TUBE, WITH APPLICATORCREAM251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-197-25GM - Gram63868-1979a4a3f66-5abc-4788-b078-d1ad5ef674c212013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KQUALITY CHOICE 3 DAY VAGINAL (MICONAZOLE NITRATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]1
MiconazoleACTIVE MOIETY7NNO0D7S5MQUALITY CHOICE 3 DAY VAGINAL (MICONAZOLE NITRATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNQUALITY CHOICE 3 DAY VAGINAL (MICONAZOLE NITRATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSQUALITY CHOICE 3 DAY VAGINAL (MICONAZOLE NITRATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MQUALITY CHOICE 3 DAY VAGINAL (MICONAZOLE NITRATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HQUALITY CHOICE 3 DAY VAGINAL (MICONAZOLE NITRATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TQUALITY CHOICE 3 DAY VAGINAL (MICONAZOLE NITRATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3QUALITY CHOICE 3 DAY VAGINAL (MICONAZOLE NITRATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XQUALITY CHOICE 3 DAY VAGINAL (MICONAZOLE NITRATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YQUALITY CHOICE 3 DAY VAGINAL (MICONAZOLE NITRATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]1
WATERINACTIVE INGREDIENT059QF0KO0RQUALITY CHOICE 3 DAY VAGINAL (MICONAZOLE NITRATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-197QUALITY CHOICE 3 DAY VAGINAL (MICONAZOLE NITRATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]1Legacy NDC, 2 package rows20130313_67b6e800-ed4f-4855-b7b2-266021014bd6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998544miconazole nitrate 4 % Vaginal CreamPSN67b6e800-ed4f-4855-b7b2-266021014bd61
998544miconazole nitrate 40 MG/ML Vaginal CreamSCD67b6e800-ed4f-4855-b7b2-266021014bd61
998544miconazole nitrate 4 % Vaginal CreamSY67b6e800-ed4f-4855-b7b2-266021014bd61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63868-197-25638680197251 in 1 CARTONHistorical