NDC 14335-080

Voriconazole

Voriconazole

Voriconazole is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Hainan Poly Pharm. Co., Ltd.. The primary component is Voriconazole.

Product ID14335-080_7f2ec2d5-59fd-3f61-e053-2a91aa0ad535
NDC14335-080
Product TypeHuman Prescription Drug
Proprietary NameVoriconazole
Generic NameVoriconazole
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-01-28
Marketing CategoryANDA / ANDA
Application NumberANDA211661
Labeler NameHainan Poly Pharm. Co., Ltd.
Substance NameVORICONAZOLE
Active Ingredient Strength10 mg/mL
Pharm ClassesAzole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 14335-080-01

1 VIAL, SINGLE-DOSE in 1 CARTON (14335-080-01) > 20 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-01-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 14335-080-01 [14335008001]

Voriconazole INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA211661
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-28

Drug Details

Active Ingredients

IngredientStrength
VORICONAZOLE10 mg/mL

OpenFDA Data

SPL SET ID:7cdda098-6301-b1b4-e053-2991aa0a957e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351209
  • UPC Code
  • 0314335080010
  • Pharmacological Class

    • Azole Antifungal [EPC]
    • Azoles [CS]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • Cytochrome P450 2C19 Inhibitors [MoA]
    • Cytochrome P450 2C9 Inhibitors [MoA]
    • Azole Antifungal [EPC]
    • Azoles [CS]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • Cytochrome P450 2C19 Inhibitors [MoA]
    • Cytochrome P450 2C9 Inhibitors [MoA]

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

    NDCBrand NameGeneric Name
    68382-735voriconazolevoriconazole
    68382-736voriconazolevoriconazole
    68462-572voriconazolevoriconazole
    68462-573voriconazolevoriconazole
    70436-029voriconazolevoriconazole
    70710-1247VORICONAZOLEVORICONAZOLE
    70771-1413VORICONAZOLEVORICONAZOLE
    0781-3416VoriconazoleVoriconazole
    0781-5667voriconazolevoriconazole
    0781-5668voriconazolevoriconazole
    0904-6596voriconazolevoriconazole
    0904-6471voriconazolevoriconazole
    14335-080VoriconazoleVoriconazole
    0093-5289VoriconazoleVoriconazole
    0093-5290VoriconazoleVoriconazole
    16714-514VoriconazoleVoriconazole
    16714-515VoriconazoleVoriconazole
    27241-063VoriconazoleVoriconazole
    27241-062VoriconazoleVoriconazole
    40032-038voriconazolevoriconazole
    40032-088voriconazolevoriconazole
    40032-089voriconazolevoriconazole
    39822-1077VoriconazoleVoriconazole
    42291-900VoriconazoleVoriconazole
    43386-088voriconazolevoriconazole
    43547-377VoriconazoleVoriconazole
    43386-038VORICONAZOLEVORICONAZOLE
    43386-089voriconazolevoriconazole
    43547-378VoriconazoleVoriconazole
    47781-466VORICONAZOLEVORICONAZOLE
    51079-165VoriconazoleVoriconazole
    51079-164VoriconazoleVoriconazole
    55801-332VoriconazoleVoriconazole
    55801-333VoriconazoleVoriconazole
    59762-0934VoriconazoleVoriconazole
    59762-0936VoriconazoleVoriconazole
    59762-0935VoriconazoleVoriconazole
    59762-0930VoriconazoleVoriconazole
    60429-916voriconazolevoriconazole
    60429-915voriconazolevoriconazole
    60687-294VoriconazoleVoriconazole
    60687-273VoriconazoleVoriconazole
    61748-365VoriconazoleVoriconazole
    61748-366VoriconazoleVoriconazole
    0378-1626VoriconazoleVoriconazole
    0378-1640VoriconazoleVoriconazole
    63739-707voriconazolevoriconazole
    64980-274voriconazolevoriconazole
    64980-275voriconazolevoriconazole
    65162-913VoriconazoleVoriconazole

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