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United States · US · US:66993-456_4cdea416-6da9-411e-aa5a-ba78fc388844
DAPAGLIFLOZIN
Orange BookUNIISPLATC A10BK
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPrasco Laboratories
CountryUS (United States)
ATC codeA10BK
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11669934563030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (66993-456-30)
Annotations
UNII (FDA Substance ID)
887K2391VH
DAPAGLIFLOZIN PROPANEDIOL
RxCUI 1486966
Orange Book
N202293
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": "66993-456_4cdea416-6da9-411e-aa5a-ba78fc388844",
"productndc": "66993-456",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202293",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Jan 8, 2014"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Jan 8, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DAPAGLIFLOZIN PROPANEDIOL",
"proprietary_name": "DAPAGLIFLOZIN",
"active_ingred_unit": "mg/1",
"application_number": "NDA202293",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "DAPAGLIFLOZIN",
"start_marketing_date": "20240103",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code A10BK.
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