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United States · US · US:69097-389_3e3b16cd-011b-4f7c-9cba-05c0b57b5042
DAPAGLIFLOZIN
Orange BookUNIISPLATC A10BK
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeA10BK
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11690973890230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-389-02)
Annotations
UNII (FDA Substance ID)
887K2391VH
DAPAGLIFLOZIN PROPANEDIOL
RxCUI 1486966
Orange Book
A211535
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "887K2391VH",
"rxcui": "1486966",
"inchikey": "GOADIQFWSVMMRJ-UPGAGZFNSA-N",
"display_name": "DAPAGLIFLOZIN PROPANEDIOL",
"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": "69097-389_3e3b16cd-011b-4f7c-9cba-05c0b57b5042",
"productndc": "69097-389",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211535",
"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 PROPANEDIOL",
"proprietary_name": "DAPAGLIFLOZIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211535",
"marketing_category": "ANDA",
"nonproprietary_name": "DAPAGLIFLOZIN",
"start_marketing_date": "20260406",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code A10BK.
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