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United States · US · US:69238-2860_0bfa52f0-d4b2-4fb1-b3ee-da4cba2b18fd
Mirabegron
Orange BookUNIISPLATC G04BD12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeG04BD12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11692382860130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69238-2860-1)
- ndc11692382860290 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69238-2860-2)
Annotations
UNII (FDA Substance ID)
MVR3JL3B2V
MIRABEGRON
RxCUI 1300786
Orange Book
A218543
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "MVR3JL3B2V",
"rxcui": "1300786",
"inchikey": "PBAPPPCECJKMCM-IBGZPJMESA-N",
"display_name": "MIRABEGRON",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d0054db9-e38a-4786-be2c-996fa5b8f47d": {
"match": "brand_token",
"title": "MIRABEGRON TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.]",
"spl_version": "1",
"published_date": "2026-05-25"
}
},
"productid": "69238-2860_0bfa52f0-d4b2-4fb1-b3ee-da4cba2b18fd",
"productndc": "69238-2860",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "218543",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Nov 4, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Nov 4, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MIRABEGRON",
"proprietary_name": "Mirabegron",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218543",
"marketing_category": "ANDA",
"nonproprietary_name": "Mirabegron",
"start_marketing_date": "20260419",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code G04BD12.
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