Myrbetriq

Product NDC: 55154-8713
11-digit product format: 551548713
Labeler code: 55154
Product ID: 55154-8713_eaa551c0-5c11-45b4-9f9b-3533810c065b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mirabegron
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: NDA202611
Marketing category: NDA
Marketing start: 2012-06-28
Marketing end: 0000-00-00
Substance: MIRABEGRON
Active strength: 50 mg/1
Pharmacologic classes: Adrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], beta3-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55154-8713		D	Discontinued by firm		2026-08-07
excluded package	package	55154-8713	55154-8713-8	D	Discontinued by firm		2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N202611-001	MYRBETRIQ	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28
N202611-002	MYRBETRIQ	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N202611-001	AB
N202611-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 26 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202611-001	8772315	2028-10-30	U-2300		2018-05-17
N202611-001	8772315*PED	2029-04-30		Pediatric extension
N202611-001	10842780	2029-09-28	U-2996	Drug product	2020-12-11
N202611-001	10842780	2029-09-28	U-3670	Drug product	2020-12-11
N202611-001	11707451	2029-09-28	U-2996		2023-08-21
N202611-001	11707451	2029-09-28	U-3670		2023-08-21
N202611-001	12059409	2029-09-28		Drug product	2024-08-28
N202611-001	12097189	2029-09-28	U-2996		2024-10-02
N202611-001	12097189	2029-09-28	U-3670		2024-10-02
N202611-001	10842780*PED	2030-03-28		Pediatric extension
N202611-001	11707451*PED	2030-03-28		Pediatric extension
N202611-001	12059409*PED	2030-03-28		Pediatric extension
N202611-001	12097189*PED	2030-03-28		Pediatric extension
N202611-002	8772315	2028-10-30	U-2300		2018-05-17
N202611-002	8772315*PED	2029-04-30		Pediatric extension
N202611-002	10842780	2029-09-28	U-2996	Drug product	2020-12-11
N202611-002	10842780	2029-09-28	U-3670	Drug product	2020-12-11
N202611-002	11707451	2029-09-28	U-2996		2023-08-21
N202611-002	11707451	2029-09-28	U-3670		2023-08-21
N202611-002	12059409	2029-09-28		Drug product	2024-08-28
N202611-002	12097189	2029-09-28	U-2996		2024-10-02
N202611-002	12097189	2029-09-28	U-3670		2024-10-02
N202611-002	10842780*PED	2030-03-28		Pediatric extension
N202611-002	11707451*PED	2030-03-28		Pediatric extension
N202611-002	12059409*PED	2030-03-28		Pediatric extension
N202611-002	12097189*PED	2030-03-28		Pediatric extension

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202611-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202611-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202611-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202611-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202611-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202611-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202611-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202611-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202611-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202611-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202611-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202611-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202611-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202611-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202611-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202611-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202611-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202611-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202611-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202611-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202611-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202611-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202611-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202611-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202611-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202611-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202611-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202611-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N202611-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202611-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N202611-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202611-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202611-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202611-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202611-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202611-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202611-002	AB	1	`a67488948f0b…`

Observed Orange Book patent history#

Patent history page 1 of 26 · 1,012 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202611-001	8772315	2028-10-30	U-2300		2018-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	8772315*PED	2029-04-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	10842780	2029-09-28	U-3670	Drug product	2020-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	10842780	2029-09-28	U-2996	Drug product	2020-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	11707451	2029-09-28	U-2996		2023-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	11707451	2029-09-28	U-3670		2023-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	12059409	2029-09-28		Drug product	2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	12097189	2029-09-28	U-2996		2024-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	12097189	2029-09-28	U-3670		2024-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	10842780*PED	2030-03-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	11707451*PED	2030-03-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	12059409*PED	2030-03-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	12097189*PED	2030-03-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	8772315	2028-10-30	U-2300		2018-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	8772315*PED	2029-04-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	10842780	2029-09-28	U-3670	Drug product	2020-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	10842780	2029-09-28	U-2996	Drug product	2020-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	11707451	2029-09-28	U-2996		2023-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	11707451	2029-09-28	U-3670		2023-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	12059409	2029-09-28		Drug product	2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	12097189	2029-09-28	U-2996		2024-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	12097189	2029-09-28	U-3670		2024-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	10842780*PED	2030-03-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	11707451*PED	2030-03-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	12059409*PED	2030-03-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	12097189*PED	2030-03-28		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	8772315	2028-10-30	U-2300		2018-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	8772315*PED	2029-04-30		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	10842780	2029-09-28	U-3670	Drug product	2020-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	10842780	2029-09-28	U-2996	Drug product	2020-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	11707451	2029-09-28	U-2996		2023-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	11707451	2029-09-28	U-3670		2023-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	12059409	2029-09-28		Drug product	2024-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	12097189	2029-09-28	U-2996		2024-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	12097189	2029-09-28	U-3670		2024-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	10842780*PED	2030-03-28		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	11707451*PED	2030-03-28		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	12059409*PED	2030-03-28		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	12097189*PED	2030-03-28		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-002	8772315	2028-10-30	U-2300		2018-05-17	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202611-001	I-855	2024-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202611-001	PED	2024-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202611-002	I-855	2024-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202611-002	PED	2024-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202611-001	I-855	2024-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202611-001	PED	2024-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202611-002	I-855	2024-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202611-002	PED	2024-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202611-001	I-855	2024-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202611-001	PED	2024-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202611-002	I-855	2024-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202611-002	PED	2024-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202611-001	I-855	2024-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202611-001	PED	2024-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202611-002	I-855	2024-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202611-002	PED	2024-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202611-001	I-855	2024-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202611-001	PED	2024-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202611-002	I-855	2024-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202611-002	PED	2024-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202611-001	I-855	2024-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202611-001	PED	2024-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202611-002	I-855	2024-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202611-002	PED	2024-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202611-001	I-855	2024-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202611-001	PED	2024-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202611-002	I-855	2024-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202611-002	PED	2024-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202611-001	I-855	2024-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202611-001	PED	2024-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202611-002	I-855	2024-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202611-002	PED	2024-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202611-001	I-855	2024-03-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202611-001	PED	2024-09-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202611-002	I-855	2024-03-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202611-002	PED	2024-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202611-001	I-855	2024-03-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202611-001	PED	2024-09-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202611-002	I-855	2024-03-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202611-002	PED	2024-09-25	`5c6f7cd8ea54…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c73f394f-7cf1-bcd8-df99-a95ef4373ff6	Product name	4	20250116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-8713	MYRBETRIQ (MIRABEGRON) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH 107, LLC]	6	Legacy NDC	20241003_aaaf3bea-1b21-4edf-9300-b7159ea9ede8.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
Myrbetriq	MIRABEGRON	Astellas Pharma US, Inc.	ba9e9e15-e666-4c56-9271-2e24739cfa2d	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202611 application number: NDA202611

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MVR3JL3B2V	MIRABEGRON	223673-61-8	MIRABEGRON

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-8713-8	55154871308	1080 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55154-8713-8)	2012-06-28	0000-00-00	No	No	Current