NDC 71335-1175

fluconazole

Fluconazole

fluconazole is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Fluconazole.

Product ID71335-1175_1ba4338e-a6bf-4d58-89ce-f43d4f21b3f4
NDC71335-1175
Product TypeHuman Prescription Drug
Proprietary Namefluconazole
Generic NameFluconazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-04-06
Marketing CategoryANDA / ANDA
Application NumberANDA208963
Labeler NameBryant Ranch Prepack
Substance NameFLUCONAZOLE
Active Ingredient Strength150 mg/1
Pharm ClassesAzole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71335-1175-1

1 TABLET in 1 BLISTER PACK (71335-1175-1)
Marketing Start Date2022-02-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1175-1 [71335117501]

fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA208963
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-09

Drug Details

Active Ingredients

IngredientStrength
FLUCONAZOLE150 mg/1

OpenFDA Data

SPL SET ID:67af604c-928f-468b-ba27-ad45e95d3e7e
Manufacturer
UNII

Pharmacological Class

  • Azole Antifungal [EPC]
  • Azoles [CS]
  • Cytochrome P450 2C19 Inhibitors [MoA]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • Cytochrome P450 2C9 Inhibitors [MoA]

NDC Crossover Matching brand name "fluconazole" or generic name "Fluconazole"

NDCBrand NameGeneric Name
68001-253FluconazoleFluconazole
68001-251FluconazoleFluconazole
68001-254FluconazoleFluconazole
68001-252FluconazoleFluconazole
68071-1863FluconazoleFluconazole
68071-3344FluconazoleFluconazole
68071-4437fluconazolefluconazole
68071-4501fluconazolefluconazole
68071-4386fluconazolefluconazole
68071-4651FluconazoleFluconazole
68084-728FluconazoleFluconazole
68084-735FluconazoleFluconazole
68258-3036FluconazoleFluconazole
68462-101FluconazoleFluconazole
68462-104FluconazoleFluconazole
68462-102FluconazoleFluconazole
68462-103FluconazoleFluconazole
68788-2518FluconazoleFluconazole
68788-7045FluconazoleFluconazole
68788-7293FluconazoleFluconazole
68788-7060FluconazoleFluconazole
68788-9245FluconazoleFluconazole
68788-7203fluconazolefluconazole
68788-8963FluconazoleFluconazole
68788-7150fluconazolefluconazole
68788-8938FluconazoleFluconazole
68788-9927FluconazoleFluconazole
68788-9190FluconazoleFluconazole
68788-9988FluconazoleFluconazole
68788-9926FluconazoleFluconazole
69189-5016FluconazoleFluconazole
70518-0007FluconazoleFluconazole
70518-0562FluconazoleFluconazole
70518-0560FluconazoleFluconazole
70710-1139fluconazolefluconazole
70710-1137fluconazolefluconazole
70771-1065fluconazolefluconazole
70771-1066fluconazolefluconazole
70771-1063fluconazolefluconazole
70710-1138fluconazolefluconazole
70710-1140fluconazolefluconazole
70771-1064fluconazolefluconazole
71205-104FluconazoleFluconazole
71205-081fluconazolefluconazole
71205-094FluconazoleFluconazole
71335-0764FluconazoleFluconazole
71335-0769fluconazolefluconazole
71335-0686fluconazolefluconazole
71335-1037FluconazoleFluconazole
71335-0557FluconazoleFluconazole

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