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United States · US · US:71610-900_334f174d-fe96-517d-e063-6394a90a8d4d
Jardiance
Orange BookUNIISPLATC A10BK03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeA10BK03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171610900099000 TABLET, FILM COATED in 1 BOTTLE (71610-900-09)
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": "71610-900_334f174d-fe96-517d-e063-6394a90a8d4d",
"productndc": "71610-900",
"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": "10"
}Related drugs
Other records sharing ATC code A10BK03.
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