Myrbetriq

Product NDC: 0469-5020
11-digit product format: 004695020
Labeler code: 0469
Product ID: 0469-5020_fe8998d8-cf08-4e07-b966-33e8de20abf1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mirabegron
Dosage form: GRANULE, FOR SUSPENSION, EXTENDED RELEASE
Route: ORAL
Labeler: Astellas Pharma US, Inc.
Application: NDA213801
Marketing category: NDA
Marketing start: 2021-03-25
Substance: MIRABEGRON
Active strength: 8 mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N213801-001	MYRBETRIQ GRANULES	MIRABEGRON	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2021-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N213801-001	AB

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
N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22
N213801-001	10058536*PED	2036-09-30		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.

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	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2021-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2021-03-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213801-001	AB	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213801-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 172 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	N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213801-001	10058536*PED	2036-09-30		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213801-001	10058536*PED	2036-09-30		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213801-001	10058536*PED	2036-09-30		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213801-001	10058536*PED	2036-09-30		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213801-001	10058536*PED	2036-09-30		Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213801-001	7342117*PED	2024-05-04		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213801-001	7982049*PED	2024-05-04		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213801-001	10058536*PED	2036-09-30		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213801-001	7342117*PED	2024-05-04		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213801-001	7982049*PED	2024-05-04		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213801-001	10058536*PED	2036-09-30		Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213801-001	7342117*PED	2024-05-04		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213801-001	7982049*PED	2024-05-04		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213801-001	10058536*PED	2036-10-01		Pediatric extension		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213801-001	7342117*PED	2024-05-04		Pediatric extension		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213801-001	7982049*PED	2024-05-04		Pediatric extension		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213801-001	10058536*PED	2036-09-30		Pediatric extension		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213801-001	7342117*PED	2024-05-04		Pediatric extension		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213801-001	7982049*PED	2024-05-04		Pediatric extension		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213801-001	10058536*PED	2036-10-01		Pediatric extension		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213801-001	7342117*PED	2024-05-04		Pediatric extension		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213801-001	7982049*PED	2024-05-04		Pediatric extension		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213801-001	10058536*PED	2036-10-01		Pediatric extension		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213801-001	7342117*PED	2024-05-04		Pediatric extension		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213801-001	7982049*PED	2024-05-04		Pediatric extension		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213801-001	10058536*PED	2036-10-01		Pediatric extension		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213801-001	7342117*PED	2024-05-04		Pediatric extension		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213801-001	7982049*PED	2024-05-04		Pediatric extension		`1e350fbaab3a…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 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	N213801-001	NP	2024-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213801-001	PED	2024-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213801-001	NP	2024-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213801-001	PED	2024-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213801-001	NP	2024-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213801-001	PED	2024-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213801-001	NP	2024-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213801-001	PED	2024-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213801-001	NP	2024-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213801-001	PED	2024-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213801-001	NP	2024-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213801-001	PED	2024-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213801-001	NP	2024-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213801-001	PED	2024-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213801-001	NP	2024-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213801-001	PED	2024-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213801-001	NP	2024-03-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213801-001	PED	2024-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213801-001	NP	2024-03-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213801-001	PED	2024-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213801-001	NP	2024-03-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213801-001	PED	2024-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213801-001	NP	2024-03-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213801-001	PED	2024-09-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213801-001	NP	2024-03-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N213801-001	PED	2024-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213801-001	NP	2024-03-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N213801-001	PED	2024-09-25	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213801-001	NP	2024-03-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213801-001	PED	2024-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213801-001	NP	2024-03-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N213801-001	PED	2024-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213801-001	NP	2024-03-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N213801-001	PED	2024-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213801-001	NP	2024-03-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213801-001	PED	2024-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213801-001	NP	2024-03-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213801-001	PED	2024-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213801-001	NP	2024-03-25	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213801-001	PED	2024-09-25	`a67488948f0b…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MIRABEGRON	8 mg/mL

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0469-5020-99	2024-08-19	C162847	48780-1	1e7a6dab-1740-a2ce-e063-dadaa90aadf7	These highlights do not include all the information needed to use MYRBETRIQ ® /MYRBETRIQ ® GRANULES safely and effectively. See full prescribing information for MYRBETRIQ/MYRBETRIQ GRANULES. MYRBETRIQ (mirabegron extended-release tablets), for oral use MYRBETRIQ GRANULES (mirabegron for extended-release oral suspension) Initial U.S. Approval: 2012
0469-5020-99	2024-07-30	C162847	48780-1	1e7a6dab-1740-a2ce-e063-dadaa90aadf7	These highlights do not include all the information needed to use MYRBETRIQ ® /MYRBETRIQ ® GRANULES safely and effectively. See full prescribing information for MYRBETRIQ/MYRBETRIQ GRANULES. MYRBETRIQ (mirabegron extended-release tablets), for oral use MYRBETRIQ GRANULES (mirabegron for extended-release oral suspension) Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0469-5020-99	Myrbetriq	1 in 1 CARTON	GRANULE, FOR SUSPENSION, EXTENDE	1		17
0469-5020-99	Myrbetriq	100 mL in 1 BOTTLE	GRANULE, FOR SUSPENSION, EXTENDE	100		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0469-5020-99	ML - Milliliter	0469-5020	21ee1e1b-e9d1-401c-96ee-5b7d4bef3569	1	2021-09-07

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
0469-5020	MYRBETRIQ (MIRABEGRON) TABLET, FILM COATED, EXTENDED RELEASE MYRBETRIQ (MIRABEGRON) GRANULE, FOR SUSPENSION, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]	17	Current NDC, Legacy NDC, 2 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): 213801 application number: NDA213801 ndc (product): 0469-5020

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
0469-5020-99	00469502099	1 BOTTLE in 1 CARTON (0469-5020-99) / 100 mL in 1 BOTTLE	1 bottle	2021-03-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
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