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United States · US · US:70710-1380_9ca0450e-2bb5-4680-b8c8-f29148d1ddf7
Dapagliflozin
Orange BookUNIISPLATC A10BK01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA10BK01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11707101380330 TABLET in 1 BOTTLE (70710-1380-3)
- ndc11707101380990 TABLET in 1 BOTTLE (70710-1380-9)
Annotations
UNII (FDA Substance ID)
1ULL0QJ8UC
DAPAGLIFLOZIN
RxCUI 1488564
Orange Book
A211582
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": "70710-1380_9ca0450e-2bb5-4680-b8c8-f29148d1ddf7",
"productndc": "70710-1380",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211582",
"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": "ANDA211582",
"marketing_category": "ANDA",
"nonproprietary_name": "Dapagliflozin",
"start_marketing_date": "20260406",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code A10BK01.
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