MIRABEGRON

Product NDC: 70518-4665
Requested package NDC: 70518-4665-0
11-digit product format: 705184665
Labeler code: 70518
Product ID: 70518-4665_526c8ca7-1fe5-806a-e063-6394a90aa17d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mirabegron
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA209485
Marketing category: ANDA
Marketing start: 2026-05-22
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: 2027-12-31
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
A209485-001	MIRABEGRON	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB		2022-09-28
A209485-002	MIRABEGRON	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB		2022-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209485-001	AB
A209485-002	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 · 52 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
2026-02-19 14:30 UTC	2026-02	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`a67488948f0b…`

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	A209485-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209485-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209485-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209485-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209485-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209485-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209485-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209485-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209485-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209485-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209485-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209485-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209485-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209485-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209485-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209485-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209485-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209485-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209485-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209485-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209485-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209485-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209485-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209485-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209485-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209485-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209485-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209485-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209485-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209485-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209485-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209485-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209485-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209485-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209485-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209485-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209485-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209485-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209485-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209485-002	AB	1	`a67488948f0b…`

Additional Listing Data#

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

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
d0054db9-e38a-4786-be2c-996fa5b8f47d	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
70518-4665-0	MIRABEGRON	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	90		1

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MIRABEGRON	MIRABEGRON	REMEDYREPACK INC.	d0054db9-e38a-4786-be2c-996fa5b8f47d	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209485 application number: ANDA209485 ndc (package): 70518-4665-0 ndc (product): 70518-4665 ndc11 (package): 70518466500
MIRABEGRON	MIRABEGRON	Lupin Pharmaceuticals, Inc.	d22d3d12-8466-46db-bc19-d13e87c6115c	2025-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209485 application number: ANDA209485
MIRABEGRON	MIRABEGRON	Bryant Ranch Prepack	00826723-d25e-498a-b8d4-d17e5c14dda5	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209485 application number: ANDA209485
MIRABEGRON	MIRABEGRON	Bryant Ranch Prepack	1a7337a4-2901-4e65-b666-7623fadb78f2	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209485 application number: ANDA209485
MIRABEGRON	MIRABEGRON	Bryant Ranch Prepack	2965e083-b678-43b9-8e13-2efddc0daad0	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209485 application number: ANDA209485
MIRABEGRON	MIRABEGRON	Bryant Ranch Prepack	3bd73250-2b31-4b22-983b-15119846e697	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209485 application number: ANDA209485

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	d0054db9-e38a-4786-be2c-996fa5b8f47d	1
1300801	24 HR mirabegron 50 MG Extended Release Oral Tablet	SCD	d0054db9-e38a-4786-be2c-996fa5b8f47d	1
1300801	mirabegron 50 MG 24 HR Extended Release Oral Tablet	SY	d0054db9-e38a-4786-be2c-996fa5b8f47d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-4665-0	70518466500	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4665-0)	2026-05-22	No	No	Current