mirabegron

Generic: mirabegron

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirabegron
Generic Name mirabegron
Labeler zydus lifesciences limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

mirabegron 50 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1753
Product ID 70771-1753_6ad07423-8166-4871-81cd-c1e6449410e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209488
Listing Expiration 2026-12-31
Marketing Start 2024-01-23

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 707711753
Hyphenated Format 70771-1753

Supplemental Identifiers

RxCUI
1300791 1300801
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 mirabegron (source: ndc)
Generic Name mirabegron (source: ndc)
Application Number ANDA209488 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1753-1)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1753-3)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1753-9)
source: ndc

Packages (3)

70771-1753-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1753-1) 70771-1753-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1753-3) 70771-1753-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1753-9)

Ingredients (1)

mirabegron (50 mg/1)

Linked Drug Pages (1)

Mirabegron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6ad07423-8166-4871-81cd-c1e6449410e6", "openfda": {"nui": ["N0000185008", "N0000185007", "N0000182137", "N0000190114", "N0000185503"], "unii": ["MVR3JL3B2V"], "rxcui": ["1300791", "1300801"], "spl_set_id": ["461b2b94-205a-4860-9cb4-d30267ada9df"], "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": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1753-1)", "package_ndc": "70771-1753-1", "marketing_start_date": "20240123"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1753-3)", "package_ndc": "70771-1753-3", "marketing_start_date": "20240123"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1753-9)", "package_ndc": "70771-1753-9", "marketing_start_date": "20240123"}], "brand_name": "Mirabegron", "product_id": "70771-1753_6ad07423-8166-4871-81cd-c1e6449410e6", "dosage_form": "TABLET, 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": "70771-1753", "generic_name": "Mirabegron", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirabegron", "active_ingredients": [{"name": "MIRABEGRON", "strength": "50 mg/1"}], "application_number": "ANDA209488", "marketing_category": "ANDA", "marketing_start_date": "20240123", "listing_expiration_date": "20261231"}