Mirabegron

Product NDC: 70518-4304
11-digit product format: 705184304
Labeler code: 70518
Product ID: 70518-4304_402d6915-bb65-7f50-e063-6394a90a2e46
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mirabegron
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA209488
Marketing category: ANDA
Marketing start: 2025-03-07
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A209488-001	MIRABEGRON	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB		2022-09-29
A209488-002	MIRABEGRON	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB		2022-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209488-001	AB
A209488-002	AB

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 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL		2022-09-29	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL		2022-09-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL		2022-09-29	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL		2022-09-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL		2022-09-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL		2022-09-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL		2022-09-29	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL		2022-09-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209488-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL		2022-09-29	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209488-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL		2022-09-29	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209488-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209488-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209488-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209488-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209488-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209488-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209488-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209488-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209488-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209488-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209488-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209488-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209488-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209488-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209488-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209488-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209488-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209488-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209488-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209488-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209488-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209488-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209488-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209488-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209488-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209488-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209488-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209488-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209488-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209488-002	AB	1	`8072bd15b7f6…`
2023-01-26 05:58 UTC	2023-01	A209488-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209488-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209488-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209488-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209488-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A209488-002	AB	1	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209488-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209488-002	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MIRABEGRON	50 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1300801	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
5f7a1758-8691-4e53-96d6-a01626ee8140	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-4304-0	Mirabegron	90 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	90		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4304	MIRABEGRON TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]	2	Current NDC, 1 package rows	20250309_5f7a1758-8691-4e53-96d6-a01626ee8140.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mirabegron	MIRABEGRON	REMEDYREPACK INC.	b71b939e-8cb1-492c-8311-28f75dc4c682	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209488 application number: ANDA209488
Mirabegron	MIRABEGRON	REMEDYREPACK INC.	5f7a1758-8691-4e53-96d6-a01626ee8140	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209488 application number: ANDA209488 ndc (product): 70518-4304
Mirabegron	MIRABEGRON	Zydus Lifesciences Limited	461b2b94-205a-4860-9cb4-d30267ada9df	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209488 application number: ANDA209488
Mirabegron	MIRABEGRON	Zydus Pharmaceuticals (USA) Inc.	2e40eb74-3b2a-47f7-bf31-fe27484f9bd2	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209488 application number: ANDA209488

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
1300801	mirabegron 50 MG 24HR Extended Release Oral Tablet	PSN	5f7a1758-8691-4e53-96d6-a01626ee8140	3
1300801	24 HR mirabegron 50 MG Extended Release Oral Tablet	SCD	5f7a1758-8691-4e53-96d6-a01626ee8140	3
1300801	mirabegron 50 MG 24 HR Extended Release Oral Tablet	SY	5f7a1758-8691-4e53-96d6-a01626ee8140	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-4304-0	70518430400	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4304-0)	2025-03-07	No	No	Current