FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIRABEGRON25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMVR3JL3B2V
Rxcui1300791, 1300801

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c73f394f-7cf1-bcd8-df99-a95ef4373ff6Product name420250116

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-151-06MIRABEGRON30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3019
68180-151-09MIRABEGRON90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-151-06EA - Each68180-151104f227b-ca46-4a9c-8531-62a127e7a54b12024-05-16
68180-151-09EA - Each68180-1515e3d0dfa-cd9f-4084-861e-ada5bfa84fe012024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-151MIRABEGRON TABLET, FILM COATED, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]18Current NDC, 2 package rows20240906_d22d3d12-8466-46db-bc19-d13e87c6115c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1300791mirabegron 25 MG 24HR Extended Release Oral TabletPSN2965e083-b678-43b9-8e13-2efddc0daad0100
1300791mirabegron 25 MG 24HR Extended Release Oral TabletPSN3bd73250-2b31-4b22-983b-15119846e697100
130079124 HR mirabegron 25 MG Extended Release Oral TabletSCD2965e083-b678-43b9-8e13-2efddc0daad0100
130079124 HR mirabegron 25 MG Extended Release Oral TabletSCD3bd73250-2b31-4b22-983b-15119846e697100
1300791mirabegron 25 MG 24 HR Release TabletSY2965e083-b678-43b9-8e13-2efddc0daad0100
1300791mirabegron 25 MG 24 HR Release TabletSY3bd73250-2b31-4b22-983b-15119846e697100
1300791mirabegron 25 MG 24HR Extended Release Oral TabletPSNd22d3d12-8466-46db-bc19-d13e87c6115c19
1300801mirabegron 50 MG 24HR Extended Release Oral TabletPSNd22d3d12-8466-46db-bc19-d13e87c6115c19
130079124 HR mirabegron 25 MG Extended Release Oral TabletSCDd22d3d12-8466-46db-bc19-d13e87c6115c19
130080124 HR mirabegron 50 MG Extended Release Oral TabletSCDd22d3d12-8466-46db-bc19-d13e87c6115c19
1300791mirabegron 25 MG 24 HR Release TabletSYd22d3d12-8466-46db-bc19-d13e87c6115c19
1300801mirabegron 50 MG 24 HR Extended Release Oral TabletSYd22d3d12-8466-46db-bc19-d13e87c6115c19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68180-151-066818001510630 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-151-06) 2024-04-19NoNoCurrent
68180-151-096818001510990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-151-09) 2024-04-19NoNoCurrent