NDC 62332-204

ITRACONAZOLE

Itraconazole

ITRACONAZOLE is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Inc.. The primary component is Itraconazole.

• Product ID: 62332-204_19f68792-60fa-41bb-97b5-ce4fea1bd7c8
• NDC: 62332-204
• Product Type: Human Prescription Drug
• Proprietary Name: ITRACONAZOLE
• Generic Name: Itraconazole
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2016-12-16
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206741
• Labeler Name: Alembic Pharmaceuticals Inc.
• 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 62332-204-04

28 CAPSULE in 1 CARTON (62332-204-04)

• Marketing Start Date: 2016-12-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 62332-204-90 [62332020490]

ITRACONAZOLE CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA206741
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-12-16

NDC 62332-204-10 [62332020410]

ITRACONAZOLE CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA206741
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-12-16

NDC 62332-204-30 [62332020430]

ITRACONAZOLE CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA206741
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-12-16

NDC 62332-204-71 [62332020471]

ITRACONAZOLE CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA206741
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-12-16

NDC 62332-204-04 [62332020404]

ITRACONAZOLE CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA206741
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-12-16

Drug Details

Active Ingredients

Ingredient	Strength
ITRACONAZOLE	100 mg/1

OpenFDA Data

• SPL SET ID: 23126370-8d6a-4027-bd8f-860e2776ba3a
• Manufacturer:
  • Alembic Pharmaceuticals Inc.
• UNII:
  • 304NUG5GF4
• RxNorm Concept Unique ID - RxCUI:
  • 311204
• UPC Code:
  • 0362332204304

Pharmacological Class

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

Medicade Reported Pricing

62332020430 ITRACONAZOLE 100 MG CAPSULE

Pricing Unit: EA | Drug Type:

62332020404 ITRACONAZOLE 100 MG CAPSULE

Pricing Unit: EA | Drug Type:

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