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United States · US · US:70377-023_5a032c8b-d862-951c-d6ea-67bc0aa135d9
DAPAGLIFLOZIN
Orange BookUNIISPLATC A10BK
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBiocon Pharma Inc.
CountryUS (United States)
ATC codeA10BK
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11703770231130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-023-11)
- ndc1170377023121000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-023-12)
Annotations
UNII (FDA Substance ID)
U289305BKG
DAPAGLIFLOZIN 2,3-BUTANEDIOL MONOHYDRATE
Orange Book
A211470
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "U289305BKG",
"rxcui": null,
"inchikey": "TZXPFYAUQDYEQT-KWQAYMRWSA-N",
"display_name": "DAPAGLIFLOZIN 2,3-BUTANEDIOL MONOHYDRATE",
"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": "70377-023_5a032c8b-d862-951c-d6ea-67bc0aa135d9",
"productndc": "70377-023",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211470",
"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 2,3-BUTANEDIOL MONOHYDRATE",
"proprietary_name": "DAPAGLIFLOZIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211470",
"marketing_category": "ANDA",
"nonproprietary_name": "DAPAGLIFLOZIN",
"start_marketing_date": "20260501",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code A10BK.
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