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United States · US · US:72205-435_4f890458-be94-4baf-b606-83a097e1e23e
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Orange BookUNIISPLATC A10BK
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeA10BK
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11722054350130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-435-01)
- ndc117220543502400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-435-02)
- ndc11722054350360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-435-03)
Annotations
UNII (FDA Substance ID)
1ULL0QJ8UC
DAPAGLIFLOZIN
RxCUI 1488564
Orange Book
A211479
ABABABAB
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": "72205-435_4f890458-be94-4baf-b606-83a097e1e23e",
"productndc": "72205-435",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "211479",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG;500MG",
"product_no": "001",
"approval_date": "Apr 6, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG;1GM",
"product_no": "002",
"approval_date": "Apr 6, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG;500MG",
"product_no": "003",
"approval_date": "Apr 6, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG;1GM",
"product_no": "004",
"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": "ANDA211479",
"marketing_category": "ANDA",
"nonproprietary_name": "DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE",
"start_marketing_date": "20260406",
"active_numerator_strength": "5; 1000"
}Related drugs
Other records sharing ATC code A10BK.
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