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United States · US · US:45802-402_11c471e0-6c64-4f13-b6ed-d2c80bc89f20
Alogliptin and Pioglitazone
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
- ndc11458024026530 TABLET, FILM COATED in 1 BOTTLE (45802-402-65)
Annotations
UNII (FDA Substance ID)
EEN99869SC
ALOGLIPTIN BENZOATE
RxCUI 1368000
Orange Book
N022426
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": "45802-402_11c471e0-6c64-4f13-b6ed-d2c80bc89f20",
"productndc": "45802-402",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "022426",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 25MG BASE;EQ 15MG BASE",
"product_no": "001",
"approval_date": "Jan 25, 2013"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 25MG BASE;EQ 30MG BASE",
"product_no": "002",
"approval_date": "Jan 25, 2013"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 25MG BASE;EQ 45MG BASE",
"product_no": "003",
"approval_date": "Jan 25, 2013"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "004",
"approval_date": "Jan 25, 2013"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 12.5MG BASE;EQ 30MG BASE",
"product_no": "005",
"approval_date": "Jan 25, 2013"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "006",
"approval_date": "Jan 25, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE",
"proprietary_name": "Alogliptin and Pioglitazone",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA022426",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Alogliptin Benzoate and Pioglitazone hydrochloride",
"start_marketing_date": "20160408",
"active_numerator_strength": "25; 30"
}Related drugs
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