mirabgeorn

Generic: mirabegron

Labeler: qilu pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirabgeorn
Generic Name mirabegron
Labeler qilu pharmaceutical co., ltd.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

mirabegron 50 mg/1

Manufacturer
Qilu Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 67184-0572
Product ID 67184-0572_b4283ace-4312-4cab-97c2-0722339d75b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217989
Listing Expiration 2026-12-31
Marketing Start 2025-06-30

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 671840572
Hyphenated Format 67184-0572

Supplemental Identifiers

RxCUI
1300791 1300801
UPC
0367184057214 0367184057221 0367184057122 0367184057115
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 mirabgeorn (source: ndc)
Generic Name mirabegron (source: ndc)
Application Number ANDA217989 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67184-0572-1)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67184-0572-2)
source: ndc

Packages (2)

67184-0572-1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67184-0572-1) 67184-0572-2 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67184-0572-2)

Ingredients (1)

mirabegron (50 mg/1)

Linked Drug Pages (1)

Mirabegron, Mirabgeorn ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b4283ace-4312-4cab-97c2-0722339d75b9", "openfda": {"nui": ["N0000185008", "N0000185007", "N0000182137", "N0000190114", "N0000185503"], "upc": ["0367184057214", "0367184057221", "0367184057122", "0367184057115"], "unii": ["MVR3JL3B2V"], "rxcui": ["1300791", "1300801"], "spl_set_id": ["98247602-29b9-4621-8eeb-519e40b883b9"], "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": ["Qilu Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67184-0572-1)", "package_ndc": "67184-0572-1", "marketing_start_date": "20250630"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67184-0572-2)", "package_ndc": "67184-0572-2", "marketing_start_date": "20250630"}], "brand_name": "Mirabgeorn", "product_id": "67184-0572_b4283ace-4312-4cab-97c2-0722339d75b9", "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": "67184-0572", "generic_name": "mirabegron", "labeler_name": "Qilu Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirabgeorn", "active_ingredients": [{"name": "MIRABEGRON", "strength": "50 mg/1"}], "application_number": "ANDA217989", "marketing_category": "ANDA", "marketing_start_date": "20250630", "listing_expiration_date": "20261231"}