NDC 16110-245

Seysara

Sarecycline Hydrochloride

Seysara is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Almirall, Llc. The primary component is Sarecycline Hydrochloride.

Product ID16110-245_46501118-219b-42a7-ad24-65a4ad7f42db
NDC16110-245
Product TypeHuman Prescription Drug
Proprietary NameSeysara
Generic NameSarecycline Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2019-01-04
Marketing CategoryNDA / NDA
Application NumberNDA209521
Labeler NameAlmirall, LLC
Substance NameSARECYCLINE HYDROCHLORIDE
Active Ingredient Strength60 mg/1
Pharm ClassesTetracycline-class Drug [EPC],P-Glycoprotein Inhibitors [MoA],Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 16110-245-30

30 TABLET, COATED in 1 BOTTLE (16110-245-30)
Marketing Start Date2019-01-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16110-245-30 [16110024530]

Seysara TABLET, COATED
Marketing CategoryNDA
Application NumberNDA209521
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-04

Drug Details

Active Ingredients

IngredientStrength
SARECYCLINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:b200957c-3004-4988-be97-9fd619a83649
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2059029
  • 2059033
  • 2059031
  • 2059037
  • 2059023
  • 2059035
  • UPC Code
  • 0316110246307
  • 0316110247304
  • 0316110245300
  • Pharmacological Class

    • Tetracycline-class Drug [EPC]
    • P-Glycoprotein Inhibitors [MoA]
    • Tetracyclines [CS]

    NDC Crossover Matching brand name "Seysara" or generic name "Sarecycline Hydrochloride"

    NDCBrand NameGeneric Name
    16110-245Seysarasarecycline hydrochloride
    16110-246Seysarasarecycline hydrochloride
    16110-247Seysarasarecycline hydrochloride

    Trademark Results [Seysara]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SEYSARA
    SEYSARA
    87573629 5728717 Live/Registered
    ALMIRALL, LLC
    2017-08-17
    SEYSARA
    SEYSARA
    87058418 5740134 Live/Registered
    ALMIRALL, LLC
    2016-06-02

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