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United States · US · US:67877-608_50d5c427-8611-4490-8b2e-ee40ea7f9707
Dapagliflozin
Orange BookUNIISPLATC A10BK01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeA10BK01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116787760805500 TABLET, FILM COATED in 1 BOTTLE (67877-608-05)
- ndc11678776083030 TABLET, FILM COATED in 1 BOTTLE (67877-608-30)
- ndc1167877608331 BLISTER PACK in 1 CARTON (67877-608-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11678776089090 TABLET, FILM COATED in 1 BOTTLE (67877-608-90)
Annotations
UNII (FDA Substance ID)
1ULL0QJ8UC
DAPAGLIFLOZIN
RxCUI 1488564
Orange Book
A211545
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": "67877-608_50d5c427-8611-4490-8b2e-ee40ea7f9707",
"productndc": "67877-608",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211545",
"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": "ANDA211545",
"marketing_category": "ANDA",
"nonproprietary_name": "Dapagliflozin",
"start_marketing_date": "20260406",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code A10BK01.
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