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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

  • ndc11
    4580216972
    60 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"
}

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