NDC 69339-159

Itraconazole Oral

Itraconazole

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

Product ID69339-159_1f1e3211-8876-44f2-9fed-e8c9ca5df6c3
NDC69339-159
Product TypeHuman Prescription Drug
Proprietary NameItraconazole Oral
Generic NameItraconazole
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2022-04-25
Marketing CategoryANDA /
Application NumberANDA212239
Labeler NameDash Pharmaceuticals LLC
Substance NameITRACONAZOLE
Active Ingredient Strength10 mg/mL
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 69339-159-17

40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-159-17) > 10 mL in 1 CUP, UNIT-DOSE (69339-159-01)
Marketing Start Date2022-04-25
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Itraconazole Oral" 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
0259-1420OnmelITRACONAZOLE
50458-290SPORANOXITRACONAZOLE
50458-295SPORANOXitraconazole
51862-462TolsuraItraconazole

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