alogliptin and metformin hydrochloride

Orange BookUNIISPLATC A10BH

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeA10BH

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009059930
90 TABLET, FILM COATED in 1 BOTTLE (50090-5993-0)

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": "50090-5993_58968f11-76a2-4e8d-8414-dc636614dedb",
  "productndc": "50090-5993",
  "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; 1000"
}

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