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United States · US · US:50090-3481_de360b4e-6a91-4439-9f4d-475de2d8f08b
FARXIGA
Orange BookUNIISPLATC A10BK
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeA10BK
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11500903481030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3481-0)
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": {
"72ad22ae-efe6-4cd6-a302-98aaee423d69": {
"match": "brand_token",
"title": "FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]",
"spl_version": "45",
"published_date": "2026-04-30"
}
},
"productid": "50090-3481_de360b4e-6a91-4439-9f4d-475de2d8f08b",
"productndc": "50090-3481",
"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": "FARXIGA",
"active_ingred_unit": "mg/1",
"application_number": "NDA202293",
"marketing_category": "NDA",
"nonproprietary_name": "DAPAGLIFLOZIN",
"start_marketing_date": "20080114",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code A10BK.
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