Miconazole 7

Product NDC
68788-8661
11-digit product format
687888661
Labeler code
68788
Product ID
68788-8661_ee0e2b33-2eb1-482f-a324-2716c0f289fb
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA074164
Marketing category
ANDA
Marketing start
2009-04-21
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 7
Listing expiration
2026-12-31

Related Records

Active Ingredients

IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized Identifiers

FieldValues
UniiVW4H1CYW1K
Rxcui998540

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
VW4H1CYW1KMICONAZOLE NITRATE22832-87-7MICONAZOLE NITRATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8661-4687888661041 TUBE, WITH APPLICATOR in 1 CARTON (68788-8661-4) / 45 g in 1 TUBE, WITH APPLICATOR2024-05-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Miconazole Nitrate Vaginal Cream, USPPreferred Pharmaceuticals Inc.2025-08-12HUMAN OTC DRUG LABEL2