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United States · US · US:70748-106_8aa1a0ad-3c2c-4534-ad85-b536748300bf
Dapagliflozin
Orange BookUNIISPLATC A10BK01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA10BK01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11707481060630 TABLET in 1 BOTTLE (70748-106-06)
Annotations
UNII (FDA Substance ID)
1ULL0QJ8UC
DAPAGLIFLOZIN
RxCUI 1488564
Orange Book
A211531
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": "70748-106_8aa1a0ad-3c2c-4534-ad85-b536748300bf",
"productndc": "70748-106",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211531",
"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": "ANDA211531",
"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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