NDC 65162-087

Itraconazole

Itraconazole

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

Product ID65162-087_36ef8fd2-3a0a-4d90-a5d2-8dfb275f676a
NDC65162-087
Product TypeHuman Prescription Drug
Proprietary NameItraconazole
Generic NameItraconazole
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2014-04-30
Marketing CategoryANDA / ANDA
Application NumberANDA205573
Labeler NameAmneal Pharmaceuticals LLC
Substance NameITRACONAZOLE
Active Ingredient Strength10 mg/mL
Pharm ClassesAzole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65162-087-34

10 CUP, UNIT-DOSE in 1 TRAY (65162-087-34) > 10 mL in 1 CUP, UNIT-DOSE (65162-087-13)
Marketing Start Date2014-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-087-74 [65162008774]

Itraconazole SOLUTION
Marketing CategoryANDA
Application NumberANDA205573
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-04-30

Drug Details

Pharmacological Class

  • 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"

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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.