NDC 63629-8168

Itraconazole

Itraconazole

Itraconazole is a Oral Capsule, Coated Pellets in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Itraconazole.

• Product ID: 63629-8168_54e8ff12-94d9-456d-ae5d-a32ca187e380
• NDC: 63629-8168
• Product Type: Human Prescription Drug
• Proprietary Name: Itraconazole
• Generic Name: Itraconazole
• Dosage Form: Capsule, Coated Pellets
• Route of Administration: ORAL
• Marketing Start Date: 2017-06-12
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208591
• Labeler Name: Bryant Ranch Prepack
• Substance Name: ITRACONAZOLE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 63629-8168-1

30 CAPSULE, COATED PELLETS in 1 BOTTLE (63629-8168-1)

• Marketing Start Date: 2019-07-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63629-8168-1 [63629816801]

Itraconazole CAPSULE, COATED PELLETS

• Marketing Category: ANDA
• Application Number: ANDA208591
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-16

Drug Details

Active Ingredients

Ingredient	Strength
ITRACONAZOLE	100 mg/1

OpenFDA Data

• SPL SET ID: 54e8ff12-94d9-456d-ae5d-a32ca187e380
• Manufacturer:
  • Bryant Ranch Prepack
• UNII:
  • 304NUG5GF4

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 "Itraconazole" or generic name "Itraconazole"

NDC	Brand Name	Generic Name
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
67877-454	Itraconazole	Itraconazole
68151-2718	itraconazole	itraconazole
68382-697	itraconazole	itraconazole
70771-1208	itraconazole	itraconazole
59746-282	itraconazole	itraconazole
60687-299	Itraconazole	Itraconazole
62332-204	ITRACONAZOLE	ITRACONAZOLE
65162-630	Itraconazole	Itraconazole
65162-087	Itraconazole	Itraconazole
63629-8168	Itraconazole	Itraconazole
70518-2872	Itraconazole	Itraconazole
0259-1420	Onmel	ITRACONAZOLE
50458-290	SPORANOX	ITRACONAZOLE
50458-295	SPORANOX	itraconazole
51862-462	Tolsura	Itraconazole