NDC 0527-2133

POSACONAZOLE

Posaconazole

POSACONAZOLE is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Lannett Company Inc.. The primary component is Posaconazole.

Product ID0527-2133_386712ec-571f-4dfa-ab3b-cc68fbf07185
NDC0527-2133
Product TypeHuman Prescription Drug
Proprietary NamePOSACONAZOLE
Generic NamePosaconazole
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-08-28
Marketing CategoryANDA / ANDA
Application NumberANDA212411
Labeler NameLannett Company Inc.
Substance NamePOSACONAZOLE
Active Ingredient Strength100 mg/1
Pharm ClassesAzole Antifungal [EPC],Azoles [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0527-2133-30

24 TABLET, DELAYED RELEASE in 1 CARTON (0527-2133-30)
Marketing Start Date2021-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0527-2133-35 [00527213335]

POSACONAZOLE TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA212411
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-28

NDC 0527-2133-43 [00527213343]

POSACONAZOLE TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA212411
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-28

Drug Details

Active Ingredients

IngredientStrength
POSACONAZOLE100 mg/1

OpenFDA Data

SPL SET ID:94a9b028-a2bc-4f41-884d-2d6c536881fc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1482908
  • UPC Code
  • 0305272133433
  • 0305272133358
  • Pharmacological Class

    • Azole Antifungal [EPC]
    • Azoles [CS]
    • Azole Antifungal [EPC]
    • Azoles [CS]

    NDC Crossover Matching brand name "POSACONAZOLE" or generic name "Posaconazole"

    NDCBrand NameGeneric Name
    0254-2045POSACONAZOLEposaconazole
    0406-7711POSACONAZOLEposaconazole
    0527-2133POSACONAZOLEPosaconazole
    60687-523PosaconazolePosaconazole
    70748-258POSACONAZOLEPOSACONAZOLE
    0085-1328NOXAFILposaconazole
    0085-2224NOXAFILposaconazole
    0085-4324NOXAFILposaconazole
    0085-4331NOXAFILposaconazole

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