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United States · US · US:0469-5020_fe8998d8-cf08-4e07-b966-33e8de20abf1
Myrbetriq
Orange BookUNIISPLATC G04BD12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAstellas Pharma US, Inc.
CountryUS (United States)
ATC codeG04BD12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104695020991 BOTTLE in 1 CARTON (0469-5020-99) / 100 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
MVR3JL3B2V
MIRABEGRON
RxCUI 1300786
Orange Book
N213801
AB
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": {
"ba9e9e15-e666-4c56-9271-2e24739cfa2d": {
"match": "brand_token",
"title": "MYRBETRIQ (MIRABEGRON) TABLET, FILM COATED, EXTENDED RELEASE MYRBETRIQ (MIRABEGRON) GRANULE, FOR SUSPENSION, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]",
"spl_version": "17",
"published_date": "2024-08-20"
}
},
"productid": "0469-5020_fe8998d8-cf08-4e07-b966-33e8de20abf1",
"productndc": "0469-5020",
"dosage_form": "GRANULE, FOR SUSPENSION, EXTENDED RELEASE",
"orange_book": {
"appl_no": "213801",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "8MG/ML",
"product_no": "001",
"approval_date": "Mar 25, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MIRABEGRON",
"proprietary_name": "Myrbetriq",
"active_ingred_unit": "mg/mL",
"application_number": "NDA213801",
"marketing_category": "NDA",
"nonproprietary_name": "mirabegron",
"start_marketing_date": "20210325",
"active_numerator_strength": "8"
}Related drugs
Other records sharing ATC code G04BD12.
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