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United States · US · US:70710-1159_df34c0c9-8528-4fd6-a408-e1d44da0f156
Mirabegron
Orange BookUNIISPLATC G04BD12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals (USA) Inc.
CountryUS (United States)
ATC codeG04BD12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117071011591100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1159-1)
- ndc11707101159330 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1159-3)
- ndc11707101159990 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1159-9)
Annotations
UNII (FDA Substance ID)
MVR3JL3B2V
MIRABEGRON
RxCUI 1300786
Orange Book
A209488
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": "70710-1159_df34c0c9-8528-4fd6-a408-e1d44da0f156",
"productndc": "70710-1159",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "209488",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Sep 29, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Sep 29, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MIRABEGRON",
"proprietary_name": "Mirabegron",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209488",
"marketing_category": "ANDA",
"nonproprietary_name": "Mirabegron",
"start_marketing_date": "20240123",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code G04BD12.
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