NDC 72000-110

Xenleta

Lefamulin Acetate

Xenleta is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Nabriva Therapeutics Us, Inc.. The primary component is Lefamulin Acetate.

Product ID72000-110_5b6f16e1-384a-469f-91fe-9586625fce50
NDC72000-110
Product TypeHuman Prescription Drug
Proprietary NameXenleta
Generic NameLefamulin Acetate
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2019-09-09
Marketing CategoryNDA / NDA
Application NumberNDA211672
Labeler NameNabriva Therapeutics US, Inc.
Substance NameLEFAMULIN ACETATE
Active Ingredient Strength600 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 72000-110-10

10 TABLET, COATED in 1 BLISTER PACK (72000-110-10)
Marketing Start Date2019-09-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72000-110-30 [72000011030]

Xenleta TABLET, COATED
Marketing CategoryNDA
Application NumberNDA211672
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-09

Drug Details

Active Ingredients

IngredientStrength
LEFAMULIN ACETATE600 mg/1

OpenFDA Data

SPL SET ID:101db63d-2fe2-48df-8506-1382d6dcd4a3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2198953
  • 2198966
  • 2198961
  • 2198948
  • UPC Code
  • 0372000110301
  • 0372000120065
  • NDC Crossover Matching brand name "Xenleta" or generic name "Lefamulin Acetate"

    NDCBrand NameGeneric Name
    72000-110Xenletalefamulin acetate
    72000-120Xenletalefamulin acetate

    Trademark Results [Xenleta]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XENLETA
    XENLETA
    88503355 not registered Live/Pending
    Nabriva Therapeutics US, Inc.
    2019-07-08
    XENLETA
    XENLETA
    88332586 not registered Live/Pending
    Nabriva Therapeutics US, Inc.
    2019-03-08

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