MIRABEGRON

Product NDC: 68180-151
11-digit product format: 681800151
Labeler code: 68180
Product ID: 68180-151_b26f08e4-dfe4-4a0f-b6b5-e9abb495e415
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mirabegron
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA209485
Marketing category: ANDA
Marketing start: 2024-04-19
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 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
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 · 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	A209485-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209485-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-28	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209485-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209485-002	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: MIRABEGRON
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1300791	Internal RxNorm lookup
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
d22d3d12-8466-46db-bc19-d13e87c6115c	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
68180-151-06	MIRABEGRON	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		19
68180-151-09	MIRABEGRON	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-151-06	EA - Each	68180-151	104f227b-ca46-4a9c-8531-62a127e7a54b	1	2024-05-16
68180-151-09	EA - Each	68180-151	5e3d0dfa-cd9f-4084-861e-ada5bfa84fe0	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-151	MIRABEGRON TABLET, FILM COATED, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	18	Current NDC, 2 package rows	20240906_d22d3d12-8466-46db-bc19-d13e87c6115c.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 · 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
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 ndc (product): 68180-151
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
1300791	mirabegron 25 MG 24HR Extended Release Oral Tablet	PSN	2965e083-b678-43b9-8e13-2efddc0daad0	100
1300791	mirabegron 25 MG 24HR Extended Release Oral Tablet	PSN	3bd73250-2b31-4b22-983b-15119846e697	100
1300791	24 HR mirabegron 25 MG Extended Release Oral Tablet	SCD	2965e083-b678-43b9-8e13-2efddc0daad0	100
1300791	24 HR mirabegron 25 MG Extended Release Oral Tablet	SCD	3bd73250-2b31-4b22-983b-15119846e697	100
1300791	mirabegron 25 MG 24 HR Release Tablet	SY	2965e083-b678-43b9-8e13-2efddc0daad0	100
1300791	mirabegron 25 MG 24 HR Release Tablet	SY	3bd73250-2b31-4b22-983b-15119846e697	100
1300791	mirabegron 25 MG 24HR Extended Release Oral Tablet	PSN	d22d3d12-8466-46db-bc19-d13e87c6115c	19
1300801	mirabegron 50 MG 24HR Extended Release Oral Tablet	PSN	d22d3d12-8466-46db-bc19-d13e87c6115c	19
1300791	24 HR mirabegron 25 MG Extended Release Oral Tablet	SCD	d22d3d12-8466-46db-bc19-d13e87c6115c	19
1300801	24 HR mirabegron 50 MG Extended Release Oral Tablet	SCD	d22d3d12-8466-46db-bc19-d13e87c6115c	19
1300791	mirabegron 25 MG 24 HR Release Tablet	SY	d22d3d12-8466-46db-bc19-d13e87c6115c	19
1300801	mirabegron 50 MG 24 HR Extended Release Oral Tablet	SY	d22d3d12-8466-46db-bc19-d13e87c6115c	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68180-151-06	68180015106	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-151-06)	2024-04-19	No	No	Current
68180-151-09	68180015109	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-151-09)	2024-04-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MIRABEGRON	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2025-12-24	HUMAN PRESCRIPTION DRUG LABEL	19
MIRABEGRON	Bryant Ranch Prepack	2025-09-26	HUMAN PRESCRIPTION DRUG LABEL	100
MIRABEGRON	Bryant Ranch Prepack	2025-09-26	HUMAN PRESCRIPTION DRUG LABEL	100