🇺🇸
United States · US · US:72205-433_5d0fd8b1-1a08-4c86-86f3-06f7ebf6b211
Dapagliflozin
Orange BookUNIISPLATC A10BK01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeA10BK01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11722054330130 TABLET, FILM COATED in 1 BOTTLE (72205-433-01)
- ndc117220543302500 TABLET, FILM COATED in 1 BOTTLE (72205-433-02)
- ndc11722054330390 TABLET, FILM COATED in 1 BOTTLE (72205-433-03)
Annotations
UNII (FDA Substance ID)
1ULL0QJ8UC
DAPAGLIFLOZIN
RxCUI 1488564
Orange Book
A211478
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": "72205-433_5d0fd8b1-1a08-4c86-86f3-06f7ebf6b211",
"productndc": "72205-433",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211478",
"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": "ANDA211478",
"marketing_category": "ANDA",
"nonproprietary_name": "Dapagliflozin",
"start_marketing_date": "20260406",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code A10BK01.
Access this data programmatically
Query Dapagliflozin and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.