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United States · US · US:0597-0164_16f275d5-7526-4e7a-8776-665a9a6ae37a
Glyxambi
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 · 3
- ndc11059701643030 TABLET, FILM COATED in 1 BOTTLE (0597-0164-30)
- ndc11059701643930 BLISTER PACK in 1 CARTON (0597-0164-39) / 1 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11059701649090 TABLET, FILM COATED in 1 BOTTLE (0597-0164-90)
Annotations
UNII (FDA Substance ID)
HDC1R2M35U
EMPAGLIFLOZIN
RxCUI 1545653
Orange Book
N206073
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": {
"ddbab689-f76c-488c-9613-4168d41dd730": {
"match": "brand_token",
"title": "GLYXAMBI (EMPAGLIFLOZIN AND LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
"spl_version": "23",
"published_date": "2026-02-02"
}
},
"productid": "0597-0164_16f275d5-7526-4e7a-8776-665a9a6ae37a",
"productndc": "0597-0164",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "206073",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "10MG;5MG",
"product_no": "001",
"approval_date": "Jan 30, 2015"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "25MG;5MG",
"product_no": "002",
"approval_date": "Jan 30, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EMPAGLIFLOZIN; LINAGLIPTIN",
"proprietary_name": "Glyxambi",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA206073",
"marketing_category": "NDA",
"nonproprietary_name": "empagliflozin and linagliptin",
"start_marketing_date": "20150130",
"active_numerator_strength": "25; 5"
}Related drugs
Other records sharing ATC code A10BK.
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