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United States · US · US:70183-220_cd790640-aade-49e0-a549-6eac00d3efc2
INPEFA
Orange BookUNIISPLATC A10BK06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLexicon Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA10BK06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1170183220071 BLISTER PACK in 1 CARTON (70183-220-07) / 7 TABLET in 1 BLISTER PACK
- ndc11701832203030 TABLET in 1 BOTTLE (70183-220-30)
Annotations
UNII (FDA Substance ID)
6B4ZBS263Y
SOTAGLIFLOZIN
Orange Book
N216203
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6B4ZBS263Y",
"rxcui": null,
"inchikey": "QKDRXGFQVGOQKS-CRSSMBPESA-N",
"display_name": "SOTAGLIFLOZIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1a46614e-05f6-421a-b6f4-d6f8760d643a": {
"match": "brand_token",
"title": "INPEFA (SOTAGLIFLOZIN) TABLET [LEXICON PHARMACEUTICALS, INC.]",
"spl_version": "10",
"published_date": "2026-01-26"
}
},
"productid": "70183-220_cd790640-aade-49e0-a549-6eac00d3efc2",
"productndc": "70183-220",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216203",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "200MG",
"product_no": "001",
"approval_date": "May 26, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "400MG",
"product_no": "002",
"approval_date": "May 26, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SOTAGLIFLOZIN",
"proprietary_name": "INPEFA",
"active_ingred_unit": "mg/1",
"application_number": "NDA216203",
"marketing_category": "NDA",
"nonproprietary_name": "sotagliflozin",
"start_marketing_date": "20230526",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code A10BK06.
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