mirabegron

Generic: mirabegron

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirabegron
Generic Name mirabegron
Labeler remedyrepack inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

mirabegron 50 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4304
Product ID 70518-4304_402d6915-bb65-7f50-e063-6394a90a2e46
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209488
Listing Expiration 2026-12-31
Marketing Start 2025-03-07

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 705184304
Hyphenated Format 70518-4304

Supplemental Identifiers

RxCUI
1300801
UNII
MVR3JL3B2V
NUI
N0000185008 N0000185007 N0000182137 N0000190114 N0000185503

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
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4304-0)
source: ndc

Packages (1)

70518-4304-0 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4304-0)

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": "402d6915-bb65-7f50-e063-6394a90a2e46", "openfda": {"nui": ["N0000185008", "N0000185007", "N0000182137", "N0000190114", "N0000185503"], "unii": ["MVR3JL3B2V"], "rxcui": ["1300801"], "spl_set_id": ["5f7a1758-8691-4e53-96d6-a01626ee8140"], "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": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4304-0)", "package_ndc": "70518-4304-0", "marketing_start_date": "20250307"}], "brand_name": "Mirabegron", "product_id": "70518-4304_402d6915-bb65-7f50-e063-6394a90a2e46", "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": "70518-4304", "generic_name": "Mirabegron", "labeler_name": "REMEDYREPACK 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": "20250307", "listing_expiration_date": "20261231"}