NDC 77338-165

Astonea Miconazole nitrate

Antifungal

Astonea Miconazole nitrate is a Topical Powder in the Human Otc Drug category. It is labeled and distributed by Astonea Labs Private Limited. The primary component is Miconazole Nitrate.

Product ID77338-165_e69cd379-fdb4-b737-e053-2995a90aba3e
NDC77338-165
Product TypeHuman Otc Drug
Proprietary NameAstonea Miconazole nitrate
Generic NameAntifungal
Dosage FormPowder
Route of AdministrationTOPICAL
Marketing Start Date2022-08-19
Marketing CategoryOTC MONOGRAPH FINAL /
Application Numberpart333C
Labeler NameASTONEA LABS PRIVATE LIMITED
Substance NameMICONAZOLE NITRATE
Active Ingredient Strength2 g/100g
Pharm ClassesAzole Antifungal [EPC], Azoles [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 77338-165-03

85 g in 1 BOTTLE, PLASTIC (77338-165-03)
Marketing Start Date2022-08-19
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Astonea Miconazole nitrate" or generic name "Antifungal"

NDCBrand NameGeneric Name
77338-165Astonea Miconazole nitrateAntifungal
50382-004AntifungalAntifungal
68001-475Antifungal Creamantifungal
68001-478Antifungal Creamantifungal
68001-481Antifungal Creamantifungal
61767-231Blossom Pharmaceuticals Antifungalantifungal
67777-231Dynarex Antifungalantifungal
69492-014KERACTILANTIFUNGAL
50382-050MICONAZOLEantifungal
55681-165Miconazole nitrateAntifungal
68599-1471Miconazole NitrateAntifungal

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