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United States · US · US:72205-408_5cff87ef-97f9-4e3c-9e06-fd257f3cb3fb

Linagliptin and metformin hydrochloride

Orange BookUNIISPLATC A10BH

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

Identification

ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeA10BH
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7220540801
    60 TABLET, FILM COATED in 1 BOTTLE (72205-408-01)
  • ndc11
    7220540802
    180 TABLET, FILM COATED in 1 BOTTLE (72205-408-02)

Annotations

UNII (FDA Substance ID)
3X29ZEJ4R2
LINAGLIPTIN
RxCUI 1100699
Orange Book
A208459
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": {
    "cbdbd4b2-c07b-00e1-e053-2995a90a5fc9": {
      "match": "brand_token",
      "title": "LINAGLIPTIN TABLET, FILM COATED [SUNSHINE LAKE PHARMA CO., LTD.]",
      "spl_version": "6",
      "published_date": "2026-01-16"
    }
  },
  "productid": "72205-408_5cff87ef-97f9-4e3c-9e06-fd257f3cb3fb",
  "productndc": "72205-408",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208459",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;500MG",
        "product_no": "001",
        "approval_date": "Nov 3, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;850MG",
        "product_no": "002",
        "approval_date": "Nov 3, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;1GM",
        "product_no": "003",
        "approval_date": "Nov 3, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Linagliptin and metformin hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA208459",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Linagliptin and metformin hydrochloride",
  "start_marketing_date": "20251103",
  "active_numerator_strength": "2.5; 850"
}

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