TopCare

Product NDC
36800-070
11-digit product format
368000070
Labeler code
36800
Product ID
36800-070_b523b32b-f4d0-446a-8344-bdf52e578d71
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
Topco Associates 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
36800-070-092025-01-30C16284748780-12cef2736-6c6b-d83d-e063-dadaa90ab31fTopCare ® Miconazole 3 Yeast Infection Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-070-09TopCare Miconazole 3 Yeast Infection Relief1 in 1 CARTONCREAM12
36800-070-09TopCare Miconazole 3 Yeast Infection Relief25 g in 1 TUBE, WITH APPLICATORCREAM252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-070-09GM - Gram36800-0700da05170-51e6-4ee6-8ad6-f51eefc12f9312018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KTOPCARE MICONAZOLE 3 YEAST INFECTION RELIEF (MICONAZOLE NITRATE) CREAM [TOPCO ASSOCIATES LLC]1
MiconazoleACTIVE MOIETY7NNO0D7S5MTOPCARE MICONAZOLE 3 YEAST INFECTION RELIEF (MICONAZOLE NITRATE) CREAM [TOPCO ASSOCIATES LLC]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTOPCARE MICONAZOLE 3 YEAST INFECTION RELIEF (MICONAZOLE NITRATE) CREAM [TOPCO ASSOCIATES LLC]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTOPCARE MICONAZOLE 3 YEAST INFECTION RELIEF (MICONAZOLE NITRATE) CREAM [TOPCO ASSOCIATES LLC]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTOPCARE MICONAZOLE 3 YEAST INFECTION RELIEF (MICONAZOLE NITRATE) CREAM [TOPCO ASSOCIATES LLC]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTOPCARE MICONAZOLE 3 YEAST INFECTION RELIEF (MICONAZOLE NITRATE) CREAM [TOPCO ASSOCIATES LLC]1
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TTOPCARE MICONAZOLE 3 YEAST INFECTION RELIEF (MICONAZOLE NITRATE) CREAM [TOPCO ASSOCIATES LLC]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TOPCARE MICONAZOLE 3 YEAST INFECTION RELIEF (MICONAZOLE NITRATE) CREAM [TOPCO ASSOCIATES LLC]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XTOPCARE MICONAZOLE 3 YEAST INFECTION RELIEF (MICONAZOLE NITRATE) CREAM [TOPCO ASSOCIATES LLC]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTOPCARE MICONAZOLE 3 YEAST INFECTION RELIEF (MICONAZOLE NITRATE) CREAM [TOPCO ASSOCIATES LLC]1
waterINACTIVE INGREDIENT059QF0KO0RTOPCARE MICONAZOLE 3 YEAST INFECTION RELIEF (MICONAZOLE NITRATE) CREAM [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-070TOPCARE MICONAZOLE 3 YEAST INFECTION RELIEF (MICONAZOLE NITRATE) CREAM [TOPCO ASSOCIATES LLC]2Legacy NDC, 2 package rows20191106_d6f3e419-45f2-4acc-9c14-daead374aa72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998544miconazole nitrate 4 % Vaginal CreamPSNd6f3e419-45f2-4acc-9c14-daead374aa722
998544miconazole nitrate 40 MG/ML Vaginal CreamSCDd6f3e419-45f2-4acc-9c14-daead374aa722
998544miconazole nitrate 4 % Vaginal CreamSYd6f3e419-45f2-4acc-9c14-daead374aa722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-070-09368000070091 TUBE, WITH APPLICATOR in 1 CARTON (36800-070-09) > 25 g in 1 TUBE, WITH APPLICATOR2013-01-160000-00-00NoNoCurrent