mirabegron

Generic: mirabegron

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirabegron
Generic Name mirabegron
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

mirabegron 50 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 70710-1160
Product ID 70710-1160_df34c0c9-8528-4fd6-a408-e1d44da0f156
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 707101160
Hyphenated Format 70710-1160

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 (70710-1160-1)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1160-3)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1160-9)
source: ndc

Packages (3)

70710-1160-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1160-1) 70710-1160-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1160-3) 70710-1160-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1160-9)

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": "df34c0c9-8528-4fd6-a408-e1d44da0f156", "openfda": {"nui": ["N0000185008", "N0000185007", "N0000182137", "N0000190114", "N0000185503"], "unii": ["MVR3JL3B2V"], "rxcui": ["1300791", "1300801"], "spl_set_id": ["2e40eb74-3b2a-47f7-bf31-fe27484f9bd2"], "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 Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1160-1)", "package_ndc": "70710-1160-1", "marketing_start_date": "20240123"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1160-3)", "package_ndc": "70710-1160-3", "marketing_start_date": "20240123"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1160-9)", "package_ndc": "70710-1160-9", "marketing_start_date": "20240123"}], "brand_name": "Mirabegron", "product_id": "70710-1160_df34c0c9-8528-4fd6-a408-e1d44da0f156", "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": "70710-1160", "generic_name": "Mirabegron", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "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"}