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United States · US · US:0597-0140_80d5d700-e711-462e-b291-3684a78d00b8

Tradjenta

Orange BookUNIISPLATC A10BH05

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

Identification

ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA10BH05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    0597014030
    30 TABLET, FILM COATED in 1 BOTTLE (0597-0140-30)
  • ndc11
    0597014061
    100 BLISTER PACK in 1 CARTON (0597-0140-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    0597014070
    7 BLISTER PACK in 1 CARTON (0597-0140-70) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    0597014090
    90 TABLET, FILM COATED in 1 BOTTLE (0597-0140-90)

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": "0597-0140_80d5d700-e711-462e-b291-3684a78d00b8",
  "productndc": "0597-0140",
  "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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