🇺🇸
United States · US · US:63304-028_c086422b-82cd-4a82-90e1-4369dbea7f02
Dapagliflozin and Metformin Hydrochloride
Orange BookUNIISPLATC A10BK
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeA10BK
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11633040283030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-028-30)
- ndc116330402854400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-028-54)
Annotations
UNII (FDA Substance ID)
1ULL0QJ8UC
DAPAGLIFLOZIN
RxCUI 1488564
Orange Book
A211491
ABABAB
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": "63304-028_c086422b-82cd-4a82-90e1-4369dbea7f02",
"productndc": "63304-028",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "211491",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG;1GM",
"product_no": "001",
"approval_date": "Apr 6, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG;500MG",
"product_no": "002",
"approval_date": "Apr 6, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG;1GM",
"product_no": "003",
"approval_date": "Apr 6, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"proprietary_name": "Dapagliflozin and Metformin Hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA211491",
"marketing_category": "ANDA",
"nonproprietary_name": "Dapagliflozin and Metformin Hydrochloride",
"start_marketing_date": "20260406",
"active_numerator_strength": "10; 1000"
}Related drugs
Other records sharing ATC code A10BK.
Access this data programmatically
Query Dapagliflozin and Metformin Hydrochloride 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.