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United States · US · US:59651-154_513bdf9f-774c-4f7f-935a-54d3885e80a4
Dapagliflozin and Metformin hydrochloride
Orange BookUNIISPLATC A10BK
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeA10BK
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115965115405500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-154-05)
- ndc11596511543030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-154-30)
Annotations
UNII (FDA Substance ID)
1ULL0QJ8UC
DAPAGLIFLOZIN
RxCUI 1488564
Orange Book
A211489
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1ULL0QJ8UC",
"rxcui": "1488564",
"inchikey": "JVHXJTBJCFBINQ-ADAARDCZSA-N",
"display_name": "DAPAGLIFLOZIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"52a778e7-6044-2049-e063-6294a90aa0b7": {
"match": "brand_token",
"title": "DAPAGLIFLOZIN TABLET, FILM COATED [AVKARE]",
"spl_version": "2",
"published_date": "2026-05-28"
}
},
"productid": "59651-154_513bdf9f-774c-4f7f-935a-54d3885e80a4",
"productndc": "59651-154",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "211489",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG;500MG",
"product_no": "001",
"approval_date": "Apr 6, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG;1GM",
"product_no": "002",
"approval_date": "Apr 6, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG;500MG",
"product_no": "003",
"approval_date": "Apr 6, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG;1GM",
"product_no": "004",
"approval_date": "Apr 6, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"proprietary_name": "Dapagliflozin and Metformin hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA211489",
"marketing_category": "ANDA",
"nonproprietary_name": "Dapagliflozin and Metformin hydrochloride",
"start_marketing_date": "20260406",
"active_numerator_strength": "5; 500"
}Related drugs
Other records sharing ATC code A10BK.
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