Miconazole Nitrate

Product NDC
36800-385
11-digit product format
368000385
Labeler code
36800
Product ID
36800-385_2655afa6-4595-89ba-e063-6394a90a22c5
Type
HUMAN OTC DRUG
Nonproprietary name
Anti-fungal Powder Miconazole Nitrate Talc Free
Dosage form
POWDER
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-07
Marketing end
2026-09-30
Substance
MICONAZOLE NITRATE
Active strength
1.42 g/71g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Miconazole Nitrate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE1.42 g/71g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998461

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
36800-385-252023-01-31C16284748780-1f386c64a-0209-0266-e053-dadaa90a7c1aTopcare Miconazorb Anti Fungal Powder Talc Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-385-25Miconazole Nitrate71 g in 1 BOTTLE, PLASTICPOWDER717

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-385-25GM - Gram36800-385e5547636-3587-4e2a-ac8e-4883fce6745c12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-385MICONAZOLE NITRATE (ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE) POWDER [TOPCO ASSOCIATES LLC]7Current NDC, Legacy NDC, 1 package rows20241109_0afaf920-e30a-4a7c-a19e-558b31ae7e58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSN0afaf920-e30a-4a7c-a19e-558b31ae7e587
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD0afaf920-e30a-4a7c-a19e-558b31ae7e587
998461miconazole nitrate 2 % Topical PowderSY0afaf920-e30a-4a7c-a19e-558b31ae7e587

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-385-253680003852571 g in 1 BOTTLE, PLASTIC (36800-385-25) 71 g2017-12-072026-09-30NoNoCurrent