🇺🇸
United States · US · US:45802-169_187b18ba-520f-45dd-9d6f-57a833962da1
alogliptin and metformin hydrochloride
Orange BookUNIISPLATC A10BH
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeA10BH
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11458021697260 TABLET, FILM COATED in 1 BOTTLE (45802-169-72)
Annotations
UNII (FDA Substance ID)
EEN99869SC
ALOGLIPTIN BENZOATE
RxCUI 1368000
Orange Book
N203414
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "EEN99869SC",
"rxcui": "1368000",
"inchikey": "KEJICOXJTRHYAK-XFULWGLBSA-N",
"display_name": "ALOGLIPTIN BENZOATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"642b1e90-701e-42f2-bac6-a4918738e2c9": {
"match": "brand_token",
"title": "ALOGLIPTIN AND PIOGLITAZONE (ALOGLIPTIN BENZOATE AND PIOGLITAZONE HYDROCHLORIDE) TABLET, FILM COATED [PADAGIS ISRAEL PHARMACEUTICALS LTD]",
"spl_version": "11",
"published_date": "2025-08-11"
}
},
"productid": "45802-169_187b18ba-520f-45dd-9d6f-57a833962da1",
"productndc": "45802-169",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "203414",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 12.5MG BASE;500MG",
"product_no": "001",
"approval_date": "Jan 25, 2013"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 12.5MG BASE;1GM",
"product_no": "002",
"approval_date": "Jan 25, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE",
"proprietary_name": "alogliptin and metformin hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA203414",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "alogliptin and metformin hydrochloride",
"start_marketing_date": "20160408",
"active_numerator_strength": "12.5; 500"
}Related drugs
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- 🇺🇸alogliptin and metformin hydrochloridePadagis Israel Pharmaceuticals Ltd
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