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United States · US · US:55154-0412_9c209f5c-9a8e-40bf-abed-1b36b368c271
Jardiance
Orange BookUNIISPLATC A10BK03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health 107, LLC
CountryUS (United States)
ATC codeA10BK03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115515404128990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0412-8)
Annotations
UNII (FDA Substance ID)
HDC1R2M35U
EMPAGLIFLOZIN
RxCUI 1545653
Orange Book
N204629
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "HDC1R2M35U",
"rxcui": "1545653",
"inchikey": "OBWASQILIWPZMG-QZMOQZSNSA-N",
"display_name": "EMPAGLIFLOZIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"5777b8a8-ada6-4950-8548-43a1de11f075": {
"match": "brand_token",
"title": "JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]",
"spl_version": "13",
"published_date": "2026-02-23"
}
},
"productid": "55154-0412_9c209f5c-9a8e-40bf-abed-1b36b368c271",
"productndc": "55154-0412",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204629",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Aug 1, 2014"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "25MG",
"product_no": "002",
"approval_date": "Aug 1, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EMPAGLIFLOZIN",
"proprietary_name": "Jardiance",
"active_ingred_unit": "mg/1",
"application_number": "NDA204629",
"marketing_category": "NDA",
"nonproprietary_name": "Empagliflozin",
"start_marketing_date": "20140801",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code A10BK03.
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