"45802-396-01" National Drug Code (NDC)

Gynazole 1 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) / 5.8 g in 1 TUBE, WITH APPLICATOR
(Padagis Israel Pharmaceuticals Ltd)

NDC Code45802-396-01
Package Description1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) / 5.8 g in 1 TUBE, WITH APPLICATOR
Product NDC45802-396
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGynazole 1
Non-Proprietary NameButoconazole Nitrate
Dosage FormCREAM
UsageVAGINAL
Start Marketing Date20150429
Marketing Category NameANDA
Application NumberANDA200923
ManufacturerPadagis Israel Pharmaceuticals Ltd
Substance NameBUTOCONAZOLE NITRATE
Strength100
Strength Unitmg/5g
Pharmacy ClassesAzole Antifungal [EPC], Azoles [CS]

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