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United States · US · US:72205-438_1cfa51fd-8406-404c-b2a8-0fc1068675fb
DAPAGLIFLOZIN AND SAXAGLIPTIN
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 · 2
- ndc11722054380130 TABLET, FILM COATED in 1 BOTTLE (72205-438-01)
- ndc11722054380290 TABLET, FILM COATED in 1 BOTTLE (72205-438-02)
Annotations
UNII (FDA Substance ID)
1ULL0QJ8UC
DAPAGLIFLOZIN
RxCUI 1488564
Orange Book
A211533
AB
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": "72205-438_1cfa51fd-8406-404c-b2a8-0fc1068675fb",
"productndc": "72205-438",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211533",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "10MG;EQ 5MG BASE",
"product_no": "001",
"approval_date": "Apr 6, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE",
"proprietary_name": "DAPAGLIFLOZIN AND SAXAGLIPTIN",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA211533",
"marketing_category": "ANDA",
"nonproprietary_name": "DAPAGLIFLOZIN AND SAXAGLIPTIN",
"start_marketing_date": "20260406",
"active_numerator_strength": "10; 5"
}Related drugs
Other records sharing ATC code A10BK.
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