MYTESI

Product NDC: 70564-802
Requested package NDC: 70564-802-60
11-digit product format: 705640802
Labeler code: 70564
Product ID: 70564-802_f9b7d7cd-31ef-4030-ae3f-10ab635d0758
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N202292-001	MYTESI	CROFELEMER	125MG	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2012-12-31

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202292-001	8962680	2031-10-31	U-1319		2015-02-24
N202292-001	9585868	2031-10-31	U-1319		2017-07-24

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 104 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202292-001	7341744	2022-06-02	U-1319	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202292-001	7341744	2022-06-02	U-1319	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202292-001	7341744	2022-06-02	U-1319	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: MYTESI
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CROFELEMER	125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PY79D6C8RX	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1364454	Internal RxNorm lookup
1806878	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
45584fba-8081-4cd1-a21e-3ea8237f62ff	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-02-08	These 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
2024-02-08	These 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
2024-01-30	These 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
2024-01-30	These 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
2020-03-05	These 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
2020-03-05	These 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
2020-01-31	These 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
2020-01-31	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
70564-802-60	MYTESI	60 in 1 BOTTLE	TABLET, COATED	60		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70564-802-02	EA - Each	70564-802	c8bf539d-fc0a-43d6-951b-3b349d3d6349	1	2016-06-14
70564-802-60	EA - Each	70564-802	d6699f6b-f3e9-47f1-bfe2-ea2107aea679	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70564-802	MYTESI (CROFELEMER) TABLET, COATED [NAPO PHARMACEUTICALS, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20240209_45584fba-8081-4cd1-a21e-3ea8237f62ff.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MYTESI	CROFELEMER	Napo Pharmaceuticals, Inc.	45584fba-8081-4cd1-a21e-3ea8237f62ff	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202292 application number: NDA202292 ndc (package): 70564-802-60 ndc (product): 70564-802 ndc11 (package): 70564080260

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PY79D6C8RX	CROFELEMER	148465-45-6	CROFELEMER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1364454	crofelemer 125 MG Delayed Release Oral Tablet	PSN	45584fba-8081-4cd1-a21e-3ea8237f62ff	7
1806878	Mytesi 125 MG Delayed Release Oral Tablet	PSN	45584fba-8081-4cd1-a21e-3ea8237f62ff	7
1806878	crofelemer 125 MG Delayed Release Oral Tablet [Mytesi]	SBD	45584fba-8081-4cd1-a21e-3ea8237f62ff	7
1364454	crofelemer 125 MG Delayed Release Oral Tablet	SCD	45584fba-8081-4cd1-a21e-3ea8237f62ff	7
1806878	Mytesi 125 MG Delayed Release Oral Tablet	SY	45584fba-8081-4cd1-a21e-3ea8237f62ff	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70564-802-60	70564080260	60 TABLET, COATED in 1 BOTTLE (70564-802-60)	2016-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MYTESI	Napo Pharmaceuticals, Inc. \| Patheon Pharmaceuticals, Inc.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	8