NDC 71715-001

NUZYRA

Omadacycline

NUZYRA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Paratek Pharmaceuticals, Inc.. The primary component is Omadacycline.

Product ID71715-001_3d8a724a-2af8-402b-abf5-5844e7bdaf2b
NDC71715-001
Product TypeHuman Prescription Drug
Proprietary NameNUZYRA
Generic NameOmadacycline
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-02-01
Marketing CategoryNDA / NDA
Application NumberNDA209817
Labeler NameParatek Pharmaceuticals, Inc.
Substance NameOMADACYCLINE
Active Ingredient Strength100 mg/5mL
Pharm ClassesTetracycline-class Antibacterial [EPC],Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 71715-001-02

10 VIAL, GLASS in 1 CARTON (71715-001-02) > 10 mL in 1 VIAL, GLASS (71715-001-01)
Marketing Start Date2019-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71715-001-01 [71715000101]

NUZYRA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA209817
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-01

NDC 71715-001-02 [71715000102]

NUZYRA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA209817
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-01

Drug Details

Active Ingredients

IngredientStrength
OMADACYCLINE100 mg/5mL

OpenFDA Data

SPL SET ID:51591524-4703-44c6-8bde-dce3e6a463d1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2059292
  • 2059274
  • 2059288
  • 2059281
  • 2059280
  • 2059283
  • 2059282
  • 2059284
  • NDC Crossover Matching brand name "NUZYRA" or generic name "Omadacycline"

    NDCBrand NameGeneric Name
    71715-001NUZYRAomadacycline
    71715-002NUZYRAomadacycline

    Trademark Results [NUZYRA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NUZYRA
    NUZYRA
    88438211 not registered Live/Pending
    Paratek Pharmaceuticals, Inc.
    2019-05-20
    NUZYRA
    NUZYRA
    87908478 5741452 Live/Registered
    Paratek Pharmaceuticals, Inc.
    2018-05-04

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