NDC 71715-002

NUZYRA

Omadacycline

NUZYRA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Paratek Pharmaceuticals, Inc.. The primary component is Omadacycline.

Product ID71715-002_3d8a724a-2af8-402b-abf5-5844e7bdaf2b
NDC71715-002
Product TypeHuman Prescription Drug
Proprietary NameNUZYRA
Generic NameOmadacycline
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-02-01
Marketing CategoryNDA / NDA
Application NumberNDA209816
Labeler NameParatek Pharmaceuticals, Inc.
Substance NameOMADACYCLINE
Active Ingredient Strength150 mg/1
Pharm ClassesTetracycline-class Antibacterial [EPC],Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 71715-002-21

1 BLISTER PACK in 1 CARTON (71715-002-21) > 6 TABLET, FILM COATED in 1 BLISTER PACK (71715-002-28)
Marketing Start Date2020-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71715-002-28 [71715000228]

NUZYRA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209816
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-14

NDC 71715-002-27 [71715000227]

NUZYRA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209816
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-01

NDC 71715-002-24 [71715000224]

NUZYRA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209816
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-01
Marketing End Date2020-02-01

NDC 71715-002-23 [71715000223]

NUZYRA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209816
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-01
Marketing End Date2020-02-01

NDC 71715-002-21 [71715000221]

NUZYRA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209816
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-01

Drug Details

Active Ingredients

IngredientStrength
OMADACYCLINE150 mg/1

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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