FDA.reportPublic FDA data

Myrbetriq

Product NDC
0469-2602
11-digit product format
004692602
Labeler code
0469
Product ID
0469-2602_fe8998d8-cf08-4e07-b966-33e8de20abf1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mirabegron
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Astellas Pharma US, Inc.
Application
NDA202611
Marketing category
NDA
Marketing start
2012-06-28
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIRABEGRON50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMVR3JL3B2V
Rxcui1300791, 1300797, 1300801, 1300803, 2541233, 2541237

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c73f394f-7cf1-bcd8-df99-a95ef4373ff6Product name420250116
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0469-2602-07Myrbetriq4 in 1 TRAYTABLET, FILM COATED, EXTENDED RE417
0469-2602-07Myrbetriq1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE117
0469-2602-30Myrbetriq1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE117
0469-2602-30Myrbetriq30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3017
0469-2602-90Myrbetriq90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9017
0469-2602-90Myrbetriq1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0469-2602-07EA - Each0469-2602b9293cdb-ad1d-4c54-b39b-a03361136c8512023-09-05
0469-2602-30EA - Each0469-2602898a775c-d313-4c3e-aee0-02e3e7aaaf2812013-02-13
0469-2602-71EA - Each0469-2602b7fa3f72-78e5-46fd-bce8-7f3c6420aeb312013-02-13
0469-2602-90EA - Each0469-2602af31e57b-7dff-4a4d-95c2-33293f7efd2612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIRABEGRONACTIVE INGREDIENTMVR3JL3B2VMYRBETRIQ (MIRABEGRON) TABLET, FILM COATED, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]5
MIRABEGRONACTIVE MOIETYMVR3JL3B2VMYRBETRIQ (MIRABEGRON) TABLET, FILM COATED, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0469-2602MYRBETRIQ (MIRABEGRON) TABLET, FILM COATED, EXTENDED RELEASE MYRBETRIQ (MIRABEGRON) GRANULE, FOR SUSPENSION, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]17Current NDC, Legacy NDC, 6 package rows20240820_ba9e9e15-e666-4c56-9271-2e24739cfa2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1300791mirabegron 25 MG 24HR Extended Release Oral TabletPSNba9e9e15-e666-4c56-9271-2e24739cfa2d17
1300801mirabegron 50 MG 24HR Extended Release Oral TabletPSNba9e9e15-e666-4c56-9271-2e24739cfa2d17
2541233mirabegron 8 MG/mL 24HR Extended Release SuspensionPSNba9e9e15-e666-4c56-9271-2e24739cfa2d17
1300797Myrbetriq 25 MG 24HR Extended Release Oral TabletPSNba9e9e15-e666-4c56-9271-2e24739cfa2d17
1300803Myrbetriq 50 MG 24HR Extended Release Oral TabletPSNba9e9e15-e666-4c56-9271-2e24739cfa2d17
2541237Myrbetriq Granules 8 MG/mL 24HR Extended Release SuspensionPSNba9e9e15-e666-4c56-9271-2e24739cfa2d17
130079724 HR mirabegron 25 MG Extended Release Oral Tablet [Myrbetriq]SBDba9e9e15-e666-4c56-9271-2e24739cfa2d17
130080324 HR mirabegron 50 MG Extended Release Oral Tablet [Myrbetriq]SBDba9e9e15-e666-4c56-9271-2e24739cfa2d17
254123724 HR mirabegron 8 MG/ML Extended Release Suspension [Myrbetriq]SBDba9e9e15-e666-4c56-9271-2e24739cfa2d17
130079124 HR mirabegron 25 MG Extended Release Oral TabletSCDba9e9e15-e666-4c56-9271-2e24739cfa2d17
130080124 HR mirabegron 50 MG Extended Release Oral TabletSCDba9e9e15-e666-4c56-9271-2e24739cfa2d17
254123324 HR mirabegron 8 MG/ML Extended Release SuspensionSCDba9e9e15-e666-4c56-9271-2e24739cfa2d17
130079724 HR Myrbetriq 25 MG Extended Release Oral TabletSYba9e9e15-e666-4c56-9271-2e24739cfa2d17
130080324 HR Myrbetriq 50 MG Extended Release Oral TabletSYba9e9e15-e666-4c56-9271-2e24739cfa2d17
254123724 HR Myrbetriq 8 MG/ML Extended Release SuspensionSYba9e9e15-e666-4c56-9271-2e24739cfa2d17
1300791mirabegron 25 MG 24 HR Release TabletSYba9e9e15-e666-4c56-9271-2e24739cfa2d17
1300801mirabegron 50 MG 24 HR Extended Release Oral TabletSYba9e9e15-e666-4c56-9271-2e24739cfa2d17
2541233mirabegron 8 MG/ML 24 HR Extended Release SuspensionSYba9e9e15-e666-4c56-9271-2e24739cfa2d17
1300797Myrbetriq 25 MG 24HR Extended Release Oral TabletSYba9e9e15-e666-4c56-9271-2e24739cfa2d17
1300803Myrbetriq 50 MG 24HR Extended Release Oral TabletSYba9e9e15-e666-4c56-9271-2e24739cfa2d17
2541237Myrbetriq 8 MG/ML 24 HR Extended Release SuspensionSYba9e9e15-e666-4c56-9271-2e24739cfa2d17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0469-2602-07004692602074 CARTON in 1 TRAY (0469-2602-07) / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK4 carton2012-06-280000-00-00YesNoCurrent
0469-2602-30004692602301 BOTTLE in 1 CARTON (0469-2602-30) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2012-06-280000-00-00NoNoCurrent
0469-2602-90004692602901 BOTTLE in 1 CARTON (0469-2602-90) / 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2012-06-280000-00-00NoNoCurrent