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United States · US · US:0469-2602_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 · 3
- ndc1104692602074 CARTON in 1 TRAY (0469-2602-07) / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1104692602301 BOTTLE in 1 CARTON (0469-2602-30) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
- ndc1104692602901 BOTTLE in 1 CARTON (0469-2602-90) / 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
MVR3JL3B2V
MIRABEGRON
RxCUI 1300786
Orange Book
N202611
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": {
"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": "0469-2602_fe8998d8-cf08-4e07-b966-33e8de20abf1",
"productndc": "0469-2602",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "202611",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Jun 28, 2012"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Jun 28, 2012"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MIRABEGRON",
"proprietary_name": "Myrbetriq",
"active_ingred_unit": "mg/1",
"application_number": "NDA202611",
"marketing_category": "NDA",
"nonproprietary_name": "mirabegron",
"start_marketing_date": "20120628",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code G04BD12.
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