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United States · US · US:45802-351_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

  • ndc11
    4580235165
    30 TABLET, FILM COATED in 1 BOTTLE (45802-351-65)

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": "45802-351_11c471e0-6c64-4f13-b6ed-d2c80bc89f20",
  "productndc": "45802-351",
  "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        "strength": "EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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; 15"
}

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