NDC 68788-9245

Fluconazole

Fluconazole

Fluconazole is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is Fluconazole.

• Product ID: 68788-9245_bc97c079-3bd8-495c-ac63-7d7c92540b0f
• NDC: 68788-9245
• Product Type: Human Prescription Drug
• Proprietary Name: Fluconazole
• Generic Name: Fluconazole
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2014-10-27
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077731
• Labeler Name: Preferred Pharmaceuticals, Inc.
• Substance Name: FLUCONAZOLE
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 68788-9245-6

60 TABLET in 1 BOTTLE (68788-9245-6)

• Marketing Start Date: 2014-10-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68788-9245-1 [68788924501]

Fluconazole TABLET

• Marketing Category: ANDA
• Application Number: ANDA077731
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-10-27
• Marketing End Date: 2019-09-20

NDC 68788-9245-5 [68788924505]

Fluconazole TABLET

• Marketing Category: ANDA
• Application Number: ANDA077731
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-10-27
• Marketing End Date: 2019-09-20

NDC 68788-9245-9 [68788924509]

Fluconazole TABLET

• Marketing Category: ANDA
• Application Number: ANDA077731
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-10-27
• Marketing End Date: 2019-09-20

NDC 68788-9245-3 [68788924503]

Fluconazole TABLET

• Marketing Category: ANDA
• Application Number: ANDA077731
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-10-27
• Marketing End Date: 2019-09-20

NDC 68788-9245-6 [68788924506]

Fluconazole TABLET

• Marketing Category: ANDA
• Application Number: ANDA077731
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-10-27
• Marketing End Date: 2019-09-20

NDC 68788-9245-0 [68788924500]

Fluconazole TABLET

• Marketing Category: ANDA
• Application Number: ANDA077731
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-10-27
• Marketing End Date: 2019-09-20

NDC 68788-9245-2 [68788924502]

Fluconazole TABLET

• Marketing Category: ANDA
• Application Number: ANDA077731
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-10-27
• Marketing End Date: 2019-09-20

Drug Details

Active Ingredients

Ingredient	Strength
FLUCONAZOLE	200 mg/1

OpenFDA Data

• SPL SET ID: 82af879c-9ecf-4f9a-b00f-779ab4104a2f
• Manufacturer:
  • Preferred Pharmaceuticals, Inc.
• UNII:
  • 8VZV102JFY
• RxNorm Concept Unique ID - RxCUI:
  • 197700

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"

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