🇺🇸
United States · US · US:43598-620_4e06c7a2-2e47-46dd-6637-03dddb2ef8c9
Saxagliptin and Metformin Hydrochloride
Orange BookUNIISPLATC A10BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr.Reddys Laboratories Inc
CountryUS (United States)
ATC codeA10BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11435986203030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43598-620-30)
Annotations
UNII (FDA Substance ID)
786Z46389E
METFORMIN HYDROCHLORIDE
RxCUI 235743
Orange Book
A207678
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "786Z46389E",
"rxcui": "235743",
"inchikey": "OETHQSJEHLVLGH-UHFFFAOYSA-N",
"display_name": "METFORMIN HYDROCHLORIDE",
"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": "43598-620_4e06c7a2-2e47-46dd-6637-03dddb2ef8c9",
"productndc": "43598-620",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "207678",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG;EQ 5MG BASE",
"product_no": "001",
"approval_date": "Aug 9, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1GM;EQ 2.5MG BASE",
"product_no": "002",
"approval_date": "Aug 9, 2023"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "1GM;EQ 5MG BASE",
"product_no": "003",
"approval_date": "Aug 9, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METFORMIN HYDROCHLORIDE; SAXAGLIPTIN",
"proprietary_name": "Saxagliptin and Metformin Hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA207678",
"marketing_category": "ANDA",
"nonproprietary_name": "Saxagliptin and Metformin Hydrochloride",
"start_marketing_date": "20230809",
"active_numerator_strength": "500; 5"
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