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United States · US · US:0781-5990_8296f538-4c23-4d6c-be53-8005b83c24b7
Dapagliflozin
Orange BookUNIISPLATC A10BK01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeA10BK01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc110781599001100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0781-5990-01)
- ndc110781599005500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0781-5990-05)
- ndc1107815990101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0781-5990-10)
- ndc11078159903130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0781-5990-31)
Annotations
UNII (FDA Substance ID)
1ULL0QJ8UC
DAPAGLIFLOZIN
RxCUI 1488564
Orange Book
A211312
ABAB
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": "0781-5990_8296f538-4c23-4d6c-be53-8005b83c24b7",
"productndc": "0781-5990",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211312",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Apr 6, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Apr 6, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DAPAGLIFLOZIN",
"proprietary_name": "Dapagliflozin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211312",
"marketing_category": "ANDA",
"nonproprietary_name": "Dapagliflozin",
"start_marketing_date": "20260406",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code A10BK01.
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