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 ID: 70564-802_4cc8dd68-287a-4146-bb77-729bca959356
• NDC: 70564-802
• Product Type: Human Prescription Drug
• Proprietary Name: MYTESI
• Generic Name: Crofelemer
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-08-01
• Marketing Category: NDA / NDA
• Application Number: NDA202292
• Labeler Name: Napo Pharmaceuticals, Inc.
• Substance Name: CROFELEMER
• Active Ingredient Strength: 125 mg/1
• Pharm Classes: Antidiarrheal [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 70564-802-60

60 TABLET, COATED in 1 BOTTLE (70564-802-60)

• Marketing Start Date: 2016-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70564-802-02 [70564080202]

MYTESI TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA202292
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-04-12
• Marketing End Date: 2016-08-30

NDC 70564-802-60 [70564080260]

MYTESI TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA202292
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-08-01
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-03-05

Drug Details

Active Ingredients

Ingredient	Strength
CROFELEMER	125 mg/1

OpenFDA Data

• SPL SET ID: 45584fba-8081-4cd1-a21e-3ea8237f62ff
• Manufacturer:
  • Napo Pharmaceuticals, Inc.
• UNII:
  • PY79D6C8RX
• RxNorm Concept Unique ID - RxCUI:
  • 1806878
  • 1364454
• UPC Code:
  • 0370564802601

Pharmacological Class

• Antidiarrheal [EPC]