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United States · US · US:0597-0175_06cb5e7a-ca7a-474a-a968-b3ddc7af1c43
Synjardy
Orange BookUNIISPLATC A10BK
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA10BK
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110597017518180 TABLET in 1 BOTTLE (0597-0175-18)
- ndc11059701756060 TABLET in 1 BOTTLE (0597-0175-60)
Annotations
UNII (FDA Substance ID)
HDC1R2M35U
EMPAGLIFLOZIN
RxCUI 1545653
Orange Book
N206111
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": {
"0fdd0255-0055-65f3-b2c0-db8fbb87beae": {
"match": "brand_token",
"title": "SYNJARDY (EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
"spl_version": "22",
"published_date": "2026-02-02"
}
},
"productid": "0597-0175_06cb5e7a-ca7a-474a-a968-b3ddc7af1c43",
"productndc": "0597-0175",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "206111",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5MG;500MG",
"product_no": "001",
"approval_date": "Aug 26, 2015"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5MG;1GM",
"product_no": "002",
"approval_date": "Aug 26, 2015"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "12.5MG;500MG",
"product_no": "003",
"approval_date": "Aug 26, 2015"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "12.5MG;1GM",
"product_no": "004",
"approval_date": "Aug 26, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"proprietary_name": "Synjardy",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA206111",
"marketing_category": "NDA",
"nonproprietary_name": "empagliflozin and metformin hydrochloride",
"start_marketing_date": "20150826",
"active_numerator_strength": "5; 1000"
}Related drugs
Other records sharing ATC code A10BK.
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