NDC 52118-001

Vibativ

Telavancin Hydrochloride

Vibativ is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Theravance, Inc.. The primary component is Telavancin Hydrochloride.

Product ID52118-001_7bc0575c-0a78-4e3c-820c-f0bcc9f8c99f
NDC52118-001
Product TypeHuman Prescription Drug
Proprietary NameVibativ
Generic NameTelavancin Hydrochloride
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2009-11-05
Marketing CategoryNDA / NDA
Application NumberNDA022110
Labeler NameTheravance, Inc.
Substance NameTELAVANCIN HYDROCHLORIDE
Active Ingredient Strength15 mg/mL
Pharm ClassesLipoglycopeptide Antibacterial [EPC],Lipoglycopeptides [EXT]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 52118-001-01

1 VIAL, SINGLE-USE in 1 CONTAINER (52118-001-01) > 50 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2009-11-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52118-001-01 [52118000101]

Vibativ INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA022110
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-05
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TELAVANCIN HYDROCHLORIDE15 mg/mL

OpenFDA Data

SPL SET ID:9fc67b76-9ba1-45ec-9749-ca3f3a6477d9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1728089
  • 1728082
  • 1728085
  • 1728087
  • Pharmacological Class

    • Lipoglycopeptide Antibacterial [EPC]
    • Lipoglycopeptides [EXT]

    NDC Crossover Matching brand name "Vibativ" or generic name "Telavancin Hydrochloride"

    NDCBrand NameGeneric Name
    52118-001Vibativtelavancin hydrochloride
    52118-002Vibativtelavancin hydrochloride
    62847-001Vibativtelavancin hydrochloride
    62847-002Vibativtelavancin hydrochloride
    66220-315VIBATIVtelavancin hydrochloride

    Trademark Results [Vibativ]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VIBATIV
    VIBATIV
    79035545 3939879 Live/Registered
    Cumberland Pharmaceuticals Inc.
    2007-01-22

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