Myrbetriq

Product NDC: 70518-2435
Requested package NDC: 70518-2435-0
11-digit product format: 705182435
Labeler code: 70518
Product ID: 70518-2435_ea71feb1-4def-1170-e053-2a95a90a62e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mirabegron
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA202611
Marketing category: NDA
Marketing start: 2019-11-19
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-2435	70518-2435-0	D	Discontinued by firm		2026-07-31

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.

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
2026-08-01 22:54:32	2026-06	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N202611-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N202611-001	8772315	2028-10-30	U-2300		2018-05-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-001	8772315*PED	2029-04-30		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-001	10842780	2029-09-28	U-3670	Drug product	2020-12-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-001	10842780	2029-09-28	U-2996	Drug product	2020-12-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-001	11707451	2029-09-28	U-2996		2023-08-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-001	11707451	2029-09-28	U-3670		2023-08-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-001	12059409	2029-09-28		Drug product	2024-08-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-001	12097189	2029-09-28	U-2996		2024-10-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-001	12097189	2029-09-28	U-3670		2024-10-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-001	10842780*PED	2030-03-28		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-001	11707451*PED	2030-03-28		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-001	12059409*PED	2030-03-28		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-001	12097189*PED	2030-03-28		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-002	8772315	2028-10-30	U-2300		2018-05-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-002	8772315*PED	2029-04-30		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-002	10842780	2029-09-28	U-3670	Drug product	2020-12-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-002	10842780	2029-09-28	U-2996	Drug product	2020-12-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-002	11707451	2029-09-28	U-2996		2023-08-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-002	11707451	2029-09-28	U-3670		2023-08-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-002	12059409	2029-09-28		Drug product	2024-08-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-002	12097189	2029-09-28	U-2996		2024-10-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-002	12097189	2029-09-28	U-3670		2024-10-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-002	10842780*PED	2030-03-28		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-002	11707451*PED	2030-03-28		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-002	12059409*PED	2030-03-28		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202611-002	12097189*PED	2030-03-28		Pediatric extension		`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2435	MYRBETRIQ (MIRABEGRON) TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.]	9	Legacy NDC	20250316_f499d877-7699-424d-bd74-7c12d1bad129.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2435-0	70518243500	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2435-0)	2019-11-19	0000-00-00	No	No	Current