Careone miconazole 7

Product NDC
41520-825
11-digit product format
415200825
Labeler code
41520
Product ID
41520-825_dd6f9159-8c07-49f6-a043-99222a327cba
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
American Sales Company
Application
ANDA074760
Marketing category
ANDA
Marketing start
2019-05-29
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
Careone miconazole 7
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
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-825-29Careone miconazole 745 g in 1 TUBECREAM452
41520-825-29Careone miconazole 71 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-825CAREONE MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [AMERICAN SALES COMPANY]2Current NDC, Legacy NDC, 2 package rows20210205_fced0f7f-31b8-4975-836e-3f38c496a450.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998540miconazole nitrate 2 % Vaginal CreamPSNfced0f7f-31b8-4975-836e-3f38c496a4502
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDfced0f7f-31b8-4975-836e-3f38c496a4502
998540miconazole nitrate 2 % Vaginal CreamSYfced0f7f-31b8-4975-836e-3f38c496a4502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-825-29415200825291 TUBE in 1 CARTON (41520-825-29) / 45 g in 1 TUBE1 tube2019-05-290000-00-00NoNoCurrent