🇺🇸
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
- ndc11722054080160 TABLET, FILM COATED in 1 BOTTLE (72205-408-01)
- ndc117220540802180 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"
}Related drugs
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