NDC 0259-1420

Onmel

Itraconazole

Onmel is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Merz Pharmaceuticals, Llc. The primary component is Itraconazole.

• Product ID: 0259-1420_80a08006-3d71-85df-e053-2991aa0aaaf7
• NDC: 0259-1420
• Product Type: Human Prescription Drug
• Proprietary Name: Onmel
• Generic Name: Itraconazole
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2012-11-01
• Marketing End Date: 2020-11-30
• Marketing Category: NDA / NDA
• Application Number: NDA022484
• Labeler Name: Merz Pharmaceuticals, LLC
• Substance Name: ITRACONAZOLE
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]
• NDC Exclude Flag: N

Packaging

NDC 0259-1420-28

2 BLISTER PACK in 1 CARTON (0259-1420-28) > 14 TABLET in 1 BLISTER PACK (0259-1420-14)

• Marketing Start Date: 2012-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0259-1420-14 [00259142014]

Onmel TABLET

• Marketing Category: NDA
• Application Number: NDA022484
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-11-01
• Marketing End Date: 2020-11-30

NDC 0259-1420-28 [00259142028]

Onmel TABLET

• Marketing Category: NDA
• Application Number: NDA022484
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-11-01
• Marketing End Date: 2020-11-30

Drug Details

Active Ingredients

Ingredient	Strength
ITRACONAZOLE	200 mg/1

OpenFDA Data

• SPL SET ID: fb8a2e5b-fd23-4977-81de-a95f4af168e2
• Manufacturer:
  • Merz Pharmaceuticals, LLC
• UNII:
  • 304NUG5GF4
• RxNorm Concept Unique ID - RxCUI:
  • 1232418
  • 992413

Pharmacological Class

• Azole Antifungal [EPC]
• Azoles [CS]
• Cytochrome P450 3A4 Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]
• Breast Cancer Resistance Protein Inhibitors [MoA]
• Azole Antifungal [EPC]
• Azoles [CS]
• Cytochrome P450 3A4 Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]
• Breast Cancer Resistance Protein Inhibitors [MoA]

NDC Crossover Matching brand name "Onmel" or generic name "Itraconazole"

NDC	Brand Name	Generic Name
0259-1420	Onmel	ITRACONAZOLE
0378-5100	Itraconazole	itraconazole
10147-0150	itraconazole	itraconazole
10147-1700	itraconazole	ITRACONAZOLE
13668-463	Itraconazole	Itraconazole
16714-743	Itraconazole	Itraconazole
16729-271	Itraconazole	ITRACONAZOLE
31722-006	Itraconazole	Itraconazole
42543-113	Itraconazole	Itraconazole
46708-204	ITRACONAZOLE	itraconazole
49884-239	Itraconazole	Itraconazole
50268-450	Itraconazole	Itraconazole
50458-290	SPORANOX	ITRACONAZOLE
50458-295	SPORANOX	itraconazole
51862-462	Tolsura	Itraconazole