Myrbetriq

Product NDC: 0469-2601
11-digit product format: 004692601
Labeler code: 0469
Product ID: 0469-2601_fe8998d8-cf08-4e07-b966-33e8de20abf1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mirabegron
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Astellas Pharma US, Inc.
Application: NDA202611
Marketing category: NDA
Marketing start: 2012-06-28
Substance: MIRABEGRON
Active strength: 25 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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MIRABEGRON	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MVR3JL3B2V	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1300791	Internal RxNorm lookup
1300797	Internal RxNorm lookup
1300801	Internal RxNorm lookup
1300803	Internal RxNorm lookup
2541233	Internal RxNorm lookup
2541237	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
ba9e9e15-e666-4c56-9271-2e24739cfa2d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c73f394f-7cf1-bcd8-df99-a95ef4373ff6	Product name	4	20250116
a90f088a-9578-47a2-8f6e-0a9d32aafec6	Product name	1	20181030
f6c90bdc-1674-455a-aadd-1b1b59e5edeb	Product name	2	20181030
f1ec5c2f-d01e-a277-5826-c7eba86ed99b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0469-2601-07	Myrbetriq	4 in 1 TRAY	TABLET, FILM COATED, EXTENDED RE	4	17
0469-2601-07	Myrbetriq	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1	17
0469-2601-30	Myrbetriq	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1	17
0469-2601-30	Myrbetriq	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	17
0469-2601-90	Myrbetriq	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90	17
0469-2601-90	Myrbetriq	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0469-2601-30	EA - Each	0469-2601	1f33830f-6c05-499c-b82d-e0ba44aac1e7	1	2013-02-13
0469-2601-71	EA - Each	0469-2601	f38d07f4-18b8-43a4-8b96-19e475477800	1	2013-02-13
0469-2601-90	EA - Each	0469-2601	01e02f00-cb96-4b4f-a61e-158cd94e94f8	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
MIRABEGRON	ACTIVE INGREDIENT	MVR3JL3B2V	MYRBETRIQ (MIRABEGRON) TABLET, FILM COATED, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]	5
MIRABEGRON	ACTIVE MOIETY	MVR3JL3B2V	MYRBETRIQ (MIRABEGRON) TABLET, FILM COATED, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0469-2601	MYRBETRIQ (MIRABEGRON) TABLET, FILM COATED, EXTENDED RELEASE MYRBETRIQ (MIRABEGRON) GRANULE, FOR SUSPENSION, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]	17	Current NDC, Legacy NDC, 6 package rows	20240820_ba9e9e15-e666-4c56-9271-2e24739cfa2d.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 ndc (product): 0469-2601

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1300791	mirabegron 25 MG 24HR Extended Release Oral Tablet	PSN	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
1300801	mirabegron 50 MG 24HR Extended Release Oral Tablet	PSN	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
2541233	mirabegron 8 MG/mL 24HR Extended Release Suspension	PSN	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
1300797	Myrbetriq 25 MG 24HR Extended Release Oral Tablet	PSN	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
1300803	Myrbetriq 50 MG 24HR Extended Release Oral Tablet	PSN	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
2541237	Myrbetriq Granules 8 MG/mL 24HR Extended Release Suspension	PSN	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
1300797	24 HR mirabegron 25 MG Extended Release Oral Tablet [Myrbetriq]	SBD	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
1300803	24 HR mirabegron 50 MG Extended Release Oral Tablet [Myrbetriq]	SBD	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
2541237	24 HR mirabegron 8 MG/ML Extended Release Suspension [Myrbetriq]	SBD	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
1300791	24 HR mirabegron 25 MG Extended Release Oral Tablet	SCD	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
1300801	24 HR mirabegron 50 MG Extended Release Oral Tablet	SCD	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
2541233	24 HR mirabegron 8 MG/ML Extended Release Suspension	SCD	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
1300797	24 HR Myrbetriq 25 MG Extended Release Oral Tablet	SY	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
1300803	24 HR Myrbetriq 50 MG Extended Release Oral Tablet	SY	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
2541237	24 HR Myrbetriq 8 MG/ML Extended Release Suspension	SY	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
1300791	mirabegron 25 MG 24 HR Release Tablet	SY	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
1300801	mirabegron 50 MG 24 HR Extended Release Oral Tablet	SY	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
2541233	mirabegron 8 MG/ML 24 HR Extended Release Suspension	SY	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
1300797	Myrbetriq 25 MG 24HR Extended Release Oral Tablet	SY	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
1300803	Myrbetriq 50 MG 24HR Extended Release Oral Tablet	SY	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17
2541237	Myrbetriq 8 MG/ML 24 HR Extended Release Suspension	SY	ba9e9e15-e666-4c56-9271-2e24739cfa2d	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0469-2601-07	00469260107	4 CARTON in 1 TRAY (0469-2601-07) / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	4 carton	2012-06-28	0000-00-00	Yes	No	Current
0469-2601-30	00469260130	1 BOTTLE in 1 CARTON (0469-2601-30) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2012-06-28	0000-00-00	No	No	Current
0469-2601-90	00469260190	1 BOTTLE in 1 CARTON (0469-2601-90) / 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2012-06-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Myrbetriq	Cardinal Health 107, LLC	2025-11-06	HUMAN PRESCRIPTION DRUG LABEL	7
Myrbetriq	Astellas Pharma US, Inc. \| Astellas Pharma Inc. \| Sumitomo Chemical Company, Limited \| Astellas Ireland Co., Ltd. \| Delpharm Meppel B.V.	2024-08-01	HUMAN PRESCRIPTION DRUG LABEL	17
Myrbetriq	REMEDYREPACK INC.	2024-03-13	HUMAN PRESCRIPTION DRUG LABEL	5