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United States · US · US:55154-0410_195b6992-7ffb-4fb1-a959-74345e5060f4

Tradjenta

Orange BookUNIISPLATC A10BH05

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

Identification

ManufacturerCardinal Health 107, LLC
CountryUS (United States)
ATC codeA10BH05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515404108
    2640 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0410-8)

Annotations

UNII (FDA Substance ID)
3X29ZEJ4R2
LINAGLIPTIN
RxCUI 1100699
Orange Book
N201280
AB
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": {
    "dfe327e8-f6ab-41e5-bdef-d520118cd83a": {
      "match": "brand_token",
      "title": "TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]",
      "spl_version": "12",
      "published_date": "2025-09-08"
    }
  },
  "productid": "55154-0410_195b6992-7ffb-4fb1-a959-74345e5060f4",
  "productndc": "55154-0410",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "201280",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 2, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LINAGLIPTIN",
  "proprietary_name": "Tradjenta",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA201280",
  "marketing_category": "NDA",
  "nonproprietary_name": "linagliptin",
  "start_marketing_date": "20110509",
  "active_numerator_strength": "5"
}

Related drugs

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