NDC 70564-802

MYTESI

Crofelemer

MYTESI is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Napo Pharmaceuticals, Inc.. The primary component is Crofelemer.

Product ID70564-802_4cc8dd68-287a-4146-bb77-729bca959356
NDC70564-802
Product TypeHuman Prescription Drug
Proprietary NameMYTESI
Generic NameCrofelemer
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2016-08-01
Marketing CategoryNDA / NDA
Application NumberNDA202292
Labeler NameNapo Pharmaceuticals, Inc.
Substance NameCROFELEMER
Active Ingredient Strength125 mg/1
Pharm ClassesAntidiarrheal [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 70564-802-60

60 TABLET, COATED in 1 BOTTLE (70564-802-60)
Marketing Start Date2016-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70564-802-02 [70564080202]

MYTESI TABLET, COATED
Marketing CategoryNDA
Application NumberNDA202292
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-12
Marketing End Date2016-08-30

NDC 70564-802-60 [70564080260]

MYTESI TABLET, COATED
Marketing CategoryNDA
Application NumberNDA202292
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-08-01
Inactivation Date2020-01-31
Reactivation Date2020-03-05

Drug Details

Active Ingredients

IngredientStrength
CROFELEMER125 mg/1

OpenFDA Data

SPL SET ID:45584fba-8081-4cd1-a21e-3ea8237f62ff
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1806878
  • 1364454
    • UPC Code
  • 0370564802601

    • Pharmacological Class

    • Antidiarrheal [EPC]

    Trademark Results [MYTESI]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MYTESI
    MYTESI
    87039259 5143495 Live/Registered
    Napo Pharmaceuticals
    2016-05-17
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