FDA.reportPublic FDA data

MIRABEGRON

Product NDC
68180-152
11-digit product format
681800152
Labeler code
68180
Product ID
68180-152_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
2024-09-03
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
MIRABEGRON
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIRABEGRON50 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
68180-152-06MIRABEGRON30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3019
68180-152-09MIRABEGRON90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-152-06EA - Each68180-15236d636e0-500e-4029-bb28-ff11b96f568f12024-10-04
68180-152-09EA - Each68180-1527f304e93-b268-41ad-be87-f7b7fb2b691e12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-152MIRABEGRON 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
1300801mirabegron 50 MG 24HR Extended Release Oral TabletPSN00826723-d25e-498a-b8d4-d17e5c14dda5100
1300801mirabegron 50 MG 24HR Extended Release Oral TabletPSN1a7337a4-2901-4e65-b666-7623fadb78f2100
130080124 HR mirabegron 50 MG Extended Release Oral TabletSCD00826723-d25e-498a-b8d4-d17e5c14dda5100
130080124 HR mirabegron 50 MG Extended Release Oral TabletSCD1a7337a4-2901-4e65-b666-7623fadb78f2100
1300801mirabegron 50 MG 24 HR Extended Release Oral TabletSY00826723-d25e-498a-b8d4-d17e5c14dda5100
1300801mirabegron 50 MG 24 HR Extended Release Oral TabletSY1a7337a4-2901-4e65-b666-7623fadb78f2100
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
1300801mirabegron 50 MG 24HR Extended Release Oral TabletPSNd0054db9-e38a-4786-be2c-996fa5b8f47d1
130080124 HR mirabegron 50 MG Extended Release Oral TabletSCDd0054db9-e38a-4786-be2c-996fa5b8f47d1
1300801mirabegron 50 MG 24 HR Extended Release Oral TabletSYd0054db9-e38a-4786-be2c-996fa5b8f47d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68180-152-066818001520630 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-152-06) 2024-09-03NoNoCurrent
68180-152-096818001520990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-152-09) 2024-09-03NoNoCurrent