FDA.reportPublic FDA data

Myrbetriq

Product NDC
0469-5020
11-digit product format
004695020
Labeler code
0469
Product ID
0469-5020_fe8998d8-cf08-4e07-b966-33e8de20abf1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mirabegron
Dosage form
GRANULE, FOR SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Astellas Pharma US, Inc.
Application
NDA213801
Marketing category
NDA
Marketing start
2021-03-25
Substance
MIRABEGRON
Active strength
8 mg/mL
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
MIRABEGRON8 mg/mL

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0469-5020-992024-08-19C16284748780-11e7a6dab-1740-a2ce-e063-dadaa90aadf7These highlights do not include all the information needed to use MYRBETRIQ ® /MYRBETRIQ ® GRANULES safely and effectively. See full prescribing information for MYRBETRIQ/MYRBETRIQ GRANULES. MYRBETRIQ (mirabegron extended-release tablets), for oral use MYRBETRIQ GRANULES (mirabegron for extended-release oral suspension) Initial U.S. Approval: 2012
0469-5020-992024-07-30C16284748780-11e7a6dab-1740-a2ce-e063-dadaa90aadf7These highlights do not include all the information needed to use MYRBETRIQ ® /MYRBETRIQ ® GRANULES safely and effectively. See full prescribing information for MYRBETRIQ/MYRBETRIQ GRANULES. MYRBETRIQ (mirabegron extended-release tablets), for oral use MYRBETRIQ GRANULES (mirabegron for extended-release oral suspension) Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0469-5020-99Myrbetriq1 in 1 CARTONGRANULE, FOR SUSPENSION, EXTENDE117
0469-5020-99Myrbetriq100 mL in 1 BOTTLEGRANULE, FOR SUSPENSION, EXTENDE10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0469-5020-99ML - Milliliter0469-502021ee1e1b-e9d1-401c-96ee-5b7d4bef356912021-09-07

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
0469-5020MYRBETRIQ (MIRABEGRON) TABLET, FILM COATED, EXTENDED RELEASE MYRBETRIQ (MIRABEGRON) GRANULE, FOR SUSPENSION, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]17Current NDC, Legacy NDC, 2 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
0469-5020-99004695020991 BOTTLE in 1 CARTON (0469-5020-99) / 100 mL in 1 BOTTLE1 bottle2021-03-250000-00-00NoNoCurrent