NDC 61748-366

Voriconazole

Voriconazole

Voriconazole is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Versapharm Incorporated. The primary component is Voriconazole.

Product ID61748-366_4939f180-1541-4143-81a7-a281bfbd01ed
NDC61748-366
Product TypeHuman Prescription Drug
Proprietary NameVoriconazole
Generic NameVoriconazole
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-09-07
Marketing CategoryANDA / ANDA
Application NumberANDA207049
Labeler NameVersaPharm Incorporated
Substance NameVORICONAZOLE
Active Ingredient Strength200 mg/1
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 Through2021-12-31

Packaging

NDC 61748-366-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61748-366-30)
Marketing Start Date2016-09-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61748-366-30 [61748036630]

Voriconazole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207049
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-07

Drug Details

Active Ingredients

IngredientStrength
VORICONAZOLE200 mg/1

OpenFDA Data

SPL SET ID:06915bfd-919e-4efb-90a5-8fd934dc516b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349435
  • 349434
  • 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

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