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FDA Approval

Miconazole Nitrate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
May 1, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Miconazole(20 mg in 1 g)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Miconazole Nitrate

Product Details

NDC Product Code
83324-233
Application Number
M005
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
May 1, 2025
ZEA MAYS (CORN) STARCHInactive
Code: O8232NY3SJClass: IACT
Code: VW4H1CYW1KClass: ACTIBQuantity: 20 mg in 1 g
ISOBUTANEInactive
Code: BXR49TP611Class: IACT
KAOLINInactive
Code: 24H4NWX5COClass: IACT
DISTEARDIMONIUM HECTORITEInactive
Code: X687XDK09LClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
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