mirabegron

Generic: mirabegron

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirabegron
Generic Name mirabegron
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

mirabegron 25 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-151
Product ID 68180-151_b26f08e4-dfe4-4a0f-b6b5-e9abb495e415
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209485
Listing Expiration 2026-12-31
Marketing Start 2024-04-19

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 68180151
Hyphenated Format 68180-151

Supplemental Identifiers

RxCUI
1300791 1300801
UPC
0368180152064 0368180151067
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 ANDA209485 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-151-06)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-151-09)
source: ndc

Packages (2)

68180-151-06 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-151-06) 68180-151-09 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-151-09)

Ingredients (1)

mirabegron (25 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": "b26f08e4-dfe4-4a0f-b6b5-e9abb495e415", "openfda": {"nui": ["N0000185008", "N0000185007", "N0000182137", "N0000190114", "N0000185503"], "upc": ["0368180152064", "0368180151067"], "unii": ["MVR3JL3B2V"], "rxcui": ["1300791", "1300801"], "spl_set_id": ["d22d3d12-8466-46db-bc19-d13e87c6115c"], "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": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-151-06)", "package_ndc": "68180-151-06", "marketing_start_date": "20240419"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-151-09)", "package_ndc": "68180-151-09", "marketing_start_date": "20240419"}], "brand_name": "MIRABEGRON", "product_id": "68180-151_b26f08e4-dfe4-4a0f-b6b5-e9abb495e415", "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": "68180-151", "generic_name": "mirabegron", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MIRABEGRON", "active_ingredients": [{"name": "MIRABEGRON", "strength": "25 mg/1"}], "application_number": "ANDA209485", "marketing_category": "ANDA", "marketing_start_date": "20240419", "listing_expiration_date": "20261231"}