NDC 65162-630

Itraconazole

Itraconazole

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

Product ID65162-630_14f9a51d-f048-4644-b94b-f8c05474cc2f
NDC65162-630
Product TypeHuman Prescription Drug
Proprietary NameItraconazole
Generic NameItraconazole
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-09-27
Marketing CategoryANDA / ANDA
Application NumberANDA205080
Labeler NameAmneal Pharmaceuticals LLC
Substance NameITRACONAZOLE
Active Ingredient Strength100 mg/1
Pharm ClassesAzole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65162-630-03

30 CAPSULE in 1 BOTTLE (65162-630-03)
Marketing Start Date2016-09-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-630-03 [65162063003]

Itraconazole CAPSULE
Marketing CategoryANDA
Application NumberANDA205080
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-27

Drug Details

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

65162063003 ITRACONAZOLE 100 MG CAPSULE

Pricing Unit: EA | Drug Type:

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

NDCBrand NameGeneric Name
0378-5100Itraconazoleitraconazole
10147-0150itraconazoleitraconazole
10147-1700itraconazoleITRACONAZOLE
13668-463ItraconazoleItraconazole
16714-743ItraconazoleItraconazole
16729-271ItraconazoleITRACONAZOLE
31722-006ItraconazoleItraconazole
42543-113ItraconazoleItraconazole
46708-204ITRACONAZOLEitraconazole
49884-239ItraconazoleItraconazole
50268-450ItraconazoleItraconazole
67877-454ItraconazoleItraconazole
68151-2718itraconazoleitraconazole
68382-697itraconazoleitraconazole
70771-1208itraconazoleitraconazole
59746-282itraconazoleitraconazole
60687-299ItraconazoleItraconazole
62332-204ITRACONAZOLEITRACONAZOLE
65162-630ItraconazoleItraconazole
65162-087ItraconazoleItraconazole
63629-8168ItraconazoleItraconazole
70518-2872ItraconazoleItraconazole
0259-1420OnmelITRACONAZOLE
50458-290SPORANOXITRACONAZOLE
50458-295SPORANOXitraconazole
51862-462TolsuraItraconazole
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