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United States · US · US:0597-0275_bded948b-6ae6-41aa-bc63-9600660a8dfc

Jentadueto XR

Orange BookUNIISPLATC A10BH

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA10BH
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0597027533
    30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0275-33)
  • ndc11
    0597027581
    90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0275-81)
  • ndc11
    0597027588
    1 BOTTLE in 1 CARTON (0597-0275-88) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
3X29ZEJ4R2
LINAGLIPTIN
RxCUI 1100699
Orange Book
N208026
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3X29ZEJ4R2",
    "rxcui": "1100699",
    "inchikey": "LTXREWYXXSTFRX-QGZVFWFLSA-N",
    "display_name": "LINAGLIPTIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f6dd9b86-0d18-95d4-2bc7-05591bfdd597": {
      "match": "brand_token",
      "title": "JENTADUETO (LINAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
      "spl_version": "45",
      "published_date": "2024-08-22"
    }
  },
  "productid": "0597-0275_bded948b-6ae6-41aa-bc63-9600660a8dfc",
  "productndc": "0597-0275",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "208026",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2.5MG;1GM",
        "product_no": "001",
        "approval_date": "May 27, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5MG;1GM",
        "product_no": "002",
        "approval_date": "May 27, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Jentadueto XR",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA208026",
  "marketing_category": "NDA",
  "nonproprietary_name": "linagliptin and metformin hydrochloride",
  "start_marketing_date": "20160527",
  "active_numerator_strength": "5; 1000"
}

Related drugs

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