NDC 36800-782

Topco Miconazole 3

Miconazole Nitrate

Topco Miconazole 3 is a Vaginal Cream in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Miconazole Nitrate.

Product ID36800-782_6381c9e2-ff95-42f8-8b4f-0031692f5931
NDC36800-782
Product TypeHuman Otc Drug
Proprietary NameTopco Miconazole 3
Generic NameMiconazole Nitrate
Dosage FormCream
Route of AdministrationVAGINAL
Marketing Start Date2020-04-27
Marketing CategoryANDA / ANDA
Application NumberANDA091366
Labeler NameTopco Associates LLC
Substance NameMICONAZOLE NITRATE
Active Ingredient Strength40 mg/g
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 36800-782-14

3 APPLICATOR in 1 CARTON (36800-782-14) > 5 g in 1 APPLICATOR
Marketing Start Date2020-04-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-782-14 [36800078214]

Topco Miconazole 3 CREAM
Marketing CategoryANDA
Application NumberANDA091366
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-04-27

Drug Details

Active Ingredients

IngredientStrength
MICONAZOLE NITRATE40 mg/g

NDC Crossover Matching brand name "Topco Miconazole 3" or generic name "Miconazole Nitrate"

NDCBrand NameGeneric Name
36800-782Topco Miconazole 3Topco Miconazole 3
0363-0557Athletes FootMiconazole Nitrate
0113-7199Basic Care miconazole 1Miconazole nitrate
0113-7070basic care miconazole 3miconazole nitrate
0113-7825basic care miconazole 7Miconazole nitrate
0067-0949DesenexMICONAZOLE NITRATE
0316-0225DesenexMICONAZOLE NITRATE
0113-0916good sense miconazole 1Miconazole nitrate
0113-9001good sense miconazole 1Miconazole nitrate
0113-0081Good Sense Miconazole 3Miconazole nitrate
0113-0214Good Sense Miconazole 7Miconazole nitrate
0113-0825good sense miconazole 7Miconazole nitrate
0179-8017Kaiser PermanenteMiconazole Nitrate
0363-0199Miconazole 1Miconazole nitrate
0363-0081Miconazole 3Miconazole nitrate
0363-0637Miconazole 3Miconazole nitrate
0363-0730Miconazole 7Miconazole Nitrate
0067-2091Vagistat-3Miconazole nitrate
0145-1501Zeasorbmiconazole nitrate
0145-1506Zeasorbmiconazole nitrate
0316-0231Zeasorbmiconazole nitrate
0316-0232Zeasorbmiconazole nitrate

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