FDA.reportPublic FDA data

MYTESI

Product NDC
70564-802
11-digit product format
705640802
Labeler code
70564
Product ID
70564-802_8640ba06-76d4-4855-a1d3-c25220b7366e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Crofelemer
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Napo Pharmaceuticals, Inc.
Application
NDA202292
Marketing category
NDA
Marketing start
2016-08-01
Substance
CROFELEMER
Active strength
125 mg/1
Pharmacologic classes
Antidiarrheal [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MYTESI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CROFELEMER125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPY79D6C8RX
Rxcui1364454, 1806878

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70564-802-602024-02-08C16284748780-19d75b9cf-e69c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MYTESI safely and effectively . See full prescribing information for MYTESI. MYTESI ® (crofelemer) delayed-release tablets for oral use Initial U.S. Approval: 2012
70564-802-602024-01-30C16284748780-19d75b9cf-e69c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MYTESI safely and effectively . See full prescribing information for MYTESI. MYTESI ® (crofelemer) delayed-release tablets for oral use Initial U.S. Approval: 2012
70564-802-602020-03-05C16284748780-19d75b9cf-e69c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MYTESI safely and effectively . See full prescribing information for MYTESI. MYTESI ® (crofelemer) delayed-release tablets for oral use Initial U.S. Approval: 2012
70564-802-602020-01-31C16284748780-19d75b9cf-e69c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MYTESI safely and effectively . See full prescribing information for MYTESI. MYTESI ® (crofelemer) delayed-release tablets for oral use Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70564-802-60MYTESI60 in 1 BOTTLETABLET, COATED607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70564-802-02EA - Each70564-802c8bf539d-fc0a-43d6-951b-3b349d3d634912016-06-14
70564-802-60EA - Each70564-802d6699f6b-f3e9-47f1-bfe2-ea2107aea67912016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70564-802MYTESI (CROFELEMER) TABLET, COATED [NAPO PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 1 package rows20240209_45584fba-8081-4cd1-a21e-3ea8237f62ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1364454crofelemer 125 MG Delayed Release Oral TabletPSN45584fba-8081-4cd1-a21e-3ea8237f62ff7
1806878Mytesi 125 MG Delayed Release Oral TabletPSN45584fba-8081-4cd1-a21e-3ea8237f62ff7
1806878crofelemer 125 MG Delayed Release Oral Tablet [Mytesi]SBD45584fba-8081-4cd1-a21e-3ea8237f62ff7
1364454crofelemer 125 MG Delayed Release Oral TabletSCD45584fba-8081-4cd1-a21e-3ea8237f62ff7
1806878Mytesi 125 MG Delayed Release Oral TabletSY45584fba-8081-4cd1-a21e-3ea8237f62ff7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70564-802-607056408026060 TABLET, COATED in 1 BOTTLE (70564-802-60) 2016-08-010000-00-00NoNoCurrent