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United States · US · US:0597-0148_f5fe93f0-69ef-4ca2-adeb-c50582e25592

Jentadueto

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 · 2

  • ndc11
    0597014818
    180 TABLET, FILM COATED in 1 BOTTLE (0597-0148-18)
  • ndc11
    0597014860
    60 TABLET, FILM COATED in 1 BOTTLE (0597-0148-60)

Annotations

UNII (FDA Substance ID)
3X29ZEJ4R2
LINAGLIPTIN
RxCUI 1100699
Orange Book
N201281
ABABAB
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": "0597-0148_f5fe93f0-69ef-4ca2-adeb-c50582e25592",
  "productndc": "0597-0148",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "201281",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2.5MG;500MG",
        "product_no": "001",
        "approval_date": "Jan 30, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2.5MG;850MG",
        "product_no": "002",
        "approval_date": "Jan 30, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "2.5MG;1GM",
        "product_no": "003",
        "approval_date": "Jan 30, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Jentadueto",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA201281",
  "marketing_category": "NDA",
  "nonproprietary_name": "linagliptin and metformin hydrochloride",
  "start_marketing_date": "20120213",
  "active_numerator_strength": "2.5; 1000"
}

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