myrbetriq

Generic: mirabegron

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name myrbetriq
Generic Name mirabegron
Labeler cardinal health 107, llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

mirabegron 25 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-8712
Product ID 55154-8712_b37c24b7-9678-407d-a6be-560252ed6dc3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202611
Marketing Start 2012-06-28
Marketing End 2026-04-30

Pharmacologic Class

Established (EPC)
beta3-adrenergic agonist [epc]
Mechanism of Action
adrenergic beta3-agonists [moa] cytochrome p450 2d6 inhibitors [moa] cytochrome p450 3a inhibitors [moa] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551548712
Hyphenated Format 55154-8712

Supplemental Identifiers

RxCUI
1300791 1300797 1300801 1300803
UPC
0355154871380 0355154871281
UNII
MVR3JL3B2V
NUI
N0000185008 N0000185007 N0000182137 N0000190114 N0000185503

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name myrbetriq (source: ndc)
Generic Name mirabegron (source: ndc)
Application Number NDA202611 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 960 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55154-8712-8)
source: ndc

Packages (1)

55154-8712-8 960 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55154-8712-8)

Ingredients (1)

mirabegron (25 mg/1)

Linked Drug Pages (1)

Myrbetriq ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b37c24b7-9678-407d-a6be-560252ed6dc3", "openfda": {"nui": ["N0000185008", "N0000185007", "N0000182137", "N0000190114", "N0000185503"], "upc": ["0355154871380", "0355154871281"], "unii": ["MVR3JL3B2V"], "rxcui": ["1300791", "1300797", "1300801", "1300803"], "spl_set_id": ["aaaf3bea-1b21-4edf-9300-b7159ea9ede8"], "pharm_class_epc": ["beta3-Adrenergic Agonist [EPC]"], "pharm_class_moa": ["Adrenergic beta3-Agonists [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "960 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55154-8712-8)", "package_ndc": "55154-8712-8", "marketing_end_date": "20260430", "marketing_start_date": "20120628"}], "brand_name": "Myrbetriq", "product_id": "55154-8712_b37c24b7-9678-407d-a6be-560252ed6dc3", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic beta3-Agonists [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "beta3-Adrenergic Agonist [EPC]"], "product_ndc": "55154-8712", "generic_name": "mirabegron", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Myrbetriq", "active_ingredients": [{"name": "MIRABEGRON", "strength": "25 mg/1"}], "application_number": "NDA202611", "marketing_category": "NDA", "marketing_end_date": "20260430", "marketing_start_date": "20120628"}