Topcare Miconazole 7

Product NDC
36800-825
11-digit product format
368000825
Labeler code
36800
Product ID
36800-825_887383d2-df39-4e9f-9b11-4fa83dc578ce
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
Topco Associates LLC
Application
ANDA074760
Marketing category
ANDA
Marketing start
2000-02-29
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
36800-825-29368000825291 TUBE, WITH APPLICATOR in 1 CARTON (36800-825-29) / 45 g in 1 TUBE, WITH APPLICATOR2000-02-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Topco Associates LLC. Miconazole 7 Drug FactsTopco Associates LLC2021-02-08HUMAN OTC DRUG LABEL4