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United States · US · US:0378-4705_5844f950-ed79-43de-a6c4-2233878a9222
Saxagliptin
Orange BookUNIISPLATC A10BH03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA10BH03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11037847057790 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4705-77)
- ndc11037847059330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4705-93)
Annotations
UNII (FDA Substance ID)
4N19ON48ZN
SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
Orange Book
A205980
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4N19ON48ZN",
"rxcui": null,
"inchikey": "AJXATZPZZXZZRE-ZEGDOHPJSA-N",
"display_name": "SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"65884427-4dde-63bb-a23f-36a7779c0a6b": {
"match": "brand_token",
"title": "SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DR.REDDYS LABORATORIES INC]",
"spl_version": "7",
"published_date": "2026-05-20"
}
},
"productid": "0378-4705_5844f950-ed79-43de-a6c4-2233878a9222",
"productndc": "0378-4705",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "205980",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2.5MG BASE",
"product_no": "001",
"approval_date": "Jul 31, 2023"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "Jul 31, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE",
"proprietary_name": "Saxagliptin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA205980",
"marketing_category": "ANDA",
"nonproprietary_name": "saxagliptin",
"start_marketing_date": "20230804",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code A10BH03.
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