myrbetriq

Generic: mirabegron

Labeler: astellas pharma us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name myrbetriq
Generic Name mirabegron
Labeler astellas pharma us, inc.
Dosage Form GRANULE, FOR SUSPENSION, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

mirabegron 8 mg/mL

Manufacturer
Astellas Pharma US, Inc.

Identifiers & Regulatory

Product NDC 0469-5020
Product ID 0469-5020_fe8998d8-cf08-4e07-b966-33e8de20abf1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213801
Listing Expiration 2026-12-31
Marketing Start 2021-03-25

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 04695020
Hyphenated Format 0469-5020

Supplemental Identifiers

RxCUI
1300791 1300797 1300801 1300803 2541233 2541237
UNII
MVR3JL3B2V
NUI
N0000185008 N0000185007 N0000182137 N0000190114 N0000185503

Packaging Origin

Original Packager
true

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 NDA213801 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0469-5020-99) / 100 mL in 1 BOTTLE
source: ndc

Packages (1)

0469-5020-99 1 BOTTLE in 1 CARTON (0469-5020-99) / 100 mL in 1 BOTTLE

Ingredients (1)

mirabegron (8 mg/mL)

Linked Drug Pages (1)

Myrbetriq ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fe8998d8-cf08-4e07-b966-33e8de20abf1", "openfda": {"nui": ["N0000185008", "N0000185007", "N0000182137", "N0000190114", "N0000185503"], "unii": ["MVR3JL3B2V"], "rxcui": ["1300791", "1300797", "1300801", "1300803", "2541233", "2541237"], "spl_set_id": ["ba9e9e15-e666-4c56-9271-2e24739cfa2d"], "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": ["Astellas Pharma US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0469-5020-99)  / 100 mL in 1 BOTTLE", "package_ndc": "0469-5020-99", "marketing_start_date": "20210325"}], "brand_name": "Myrbetriq", "product_id": "0469-5020_fe8998d8-cf08-4e07-b966-33e8de20abf1", "dosage_form": "GRANULE, FOR SUSPENSION, 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": "0469-5020", "generic_name": "mirabegron", "labeler_name": "Astellas Pharma US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Myrbetriq", "active_ingredients": [{"name": "MIRABEGRON", "strength": "8 mg/mL"}], "application_number": "NDA213801", "marketing_category": "NDA", "marketing_start_date": "20210325", "listing_expiration_date": "20261231"}