🇺🇸
United States · US · US:33342-585_4fa5c1b8-9912-4fb8-a3b9-c105fbf641a1
dapagliflozin
Orange BookUNIISPLATC A10BK01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeA10BK01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11333425850730 TABLET in 1 BOTTLE (33342-585-07)
- ndc11333425851090 TABLET in 1 BOTTLE (33342-585-10)
- ndc11333425851210 BLISTER PACK in 1 CARTON (33342-585-12) / 10 TABLET in 1 BLISTER PACK (33342-585-66)
Annotations
UNII (FDA Substance ID)
1ULL0QJ8UC
DAPAGLIFLOZIN
RxCUI 1488564
Orange Book
A211506
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": "33342-585_4fa5c1b8-9912-4fb8-a3b9-c105fbf641a1",
"productndc": "33342-585",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211506",
"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": "ANDA211506",
"marketing_category": "ANDA",
"nonproprietary_name": "dapagliflozin",
"start_marketing_date": "20260406",
"active_numerator_strength": "5"
}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.