Miconazole Nitrate

Product NDC
50090-5674
11-digit product format
500905674
Labeler code
50090
Product ID
50090-5674_d80e0a1c-83db-44b9-94b6-5e2e83c630d5
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-29
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
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
Miconazole Nitrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998483

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
50090-5674-02023-02-07C16284748780-1f386c64a-2a90-0266-e053-dadaa90a7c1aMiconazole Nitrate
50090-5674-02023-01-30C16284748780-1f386c64a-2a90-0266-e053-dadaa90a7c1aMiconazole Nitrate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5674-0Miconazole Nitrate1 in 1 CARTONCREAM16
50090-5674-0Miconazole Nitrate28 g in 1 TUBECREAM286

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5674-0GM - Gram50090-5674be657618-2f51-4df1-bb1d-331b05a3c61012022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5674MICONAZOLE NITRATE CREAM [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20231212_7d284f6f-a970-49fe-b45a-d5c6c2688bc2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN7d284f6f-a970-49fe-b45a-d5c6c2688bc26
998483miconazole nitrate 20 MG/ML Topical CreamSCD7d284f6f-a970-49fe-b45a-d5c6c2688bc26
998483miconazole nitrate 2 % Topical CreamSY7d284f6f-a970-49fe-b45a-d5c6c2688bc26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5674-0500905674001 TUBE in 1 CARTON (50090-5674-0) / 28 g in 1 TUBE1 tube2021-09-170000-00-00NoNoCurrent