Basic Care Miconazole 7

Product NDC
72288-825
11-digit product format
722880825
Labeler code
72288
Product ID
72288-825_4a828083-f5a9-46c3-a07a-3d151f155025
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
Amazon.com Services LLC
Application
ANDA074760
Marketing category
ANDA
Marketing start
2021-08-13
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
Basic Care 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-825-29Basic Care Miconazole 745 g in 1 TUBECREAM451
72288-825-29Basic Care Miconazole 71 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-825BASIC CARE MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [AMAZON.COM SERVICES LLC]1Current NDC, Legacy NDC, 2 package rows20210817_4a828083-f5a9-46c3-a07a-3d151f155025.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998540miconazole nitrate 2 % Vaginal CreamPSN4a828083-f5a9-46c3-a07a-3d151f1550251
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD4a828083-f5a9-46c3-a07a-3d151f1550251
998540miconazole nitrate 2 % Vaginal CreamSY4a828083-f5a9-46c3-a07a-3d151f1550251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-825-29722880825291 TUBE in 1 CARTON (72288-825-29) / 45 g in 1 TUBE1 tube2021-08-130000-00-00NoNoCurrent