inpefa

Generic: sotagliflozin

Labeler: lexicon pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name inpefa
Generic Name sotagliflozin
Labeler lexicon pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotagliflozin 200 mg/1

Manufacturer
Lexicon Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70183-221
Product ID 70183-221_cd790640-aade-49e0-a549-6eac00d3efc2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216203
Listing Expiration 2027-12-31
Marketing Start 2023-05-26

Pharmacologic Class

Established (EPC)
sodium-glucose cotransporter 2 inhibitor [epc]
Mechanism of Action
sodium-glucose transporter 2 inhibitors [moa] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70183221
Hyphenated Format 70183-221

Supplemental Identifiers

RxCUI
2638683 2638689 2638691 2638693
UPC
0370183221302 0300000000001 0370183241300
UNII
6B4ZBS263Y
NUI
N0000187059 N0000187058 N0000185503

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name inpefa (source: ndc)
Generic Name sotagliflozin (source: ndc)
Application Number NDA216203 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (70183-221-07) / 7 TABLET in 1 BLISTER PACK
  • 30 TABLET in 1 BOTTLE (70183-221-30)
  • 1 BLISTER PACK in 1 CARTON (70183-221-31) / 3 BLISTER PACK in 1 BLISTER PACK / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (3)

70183-221-07 1 BLISTER PACK in 1 CARTON (70183-221-07) / 7 TABLET in 1 BLISTER PACK 70183-221-30 30 TABLET in 1 BOTTLE (70183-221-30) 70183-221-31 1 BLISTER PACK in 1 CARTON (70183-221-31) / 3 BLISTER PACK in 1 BLISTER PACK / 10 TABLET in 1 BLISTER PACK

Ingredients (1)

sotagliflozin (200 mg/1)

Linked Drug Pages (1)

INPEFA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cd790640-aade-49e0-a549-6eac00d3efc2", "openfda": {"nui": ["N0000187059", "N0000187058", "N0000185503"], "upc": ["0370183221302", "0300000000001", "0370183241300"], "unii": ["6B4ZBS263Y"], "rxcui": ["2638683", "2638689", "2638691", "2638693"], "spl_set_id": ["1a46614e-05f6-421a-b6f4-d6f8760d643a"], "pharm_class_epc": ["Sodium-Glucose Cotransporter 2 Inhibitor [EPC]"], "pharm_class_moa": ["Sodium-Glucose Transporter 2 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Lexicon Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BLISTER PACK in 1 CARTON (70183-221-07)  / 7 TABLET in 1 BLISTER PACK", "package_ndc": "70183-221-07", "marketing_start_date": "20240115"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (70183-221-30)", "package_ndc": "70183-221-30", "marketing_start_date": "20240301"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (70183-221-31)  / 3 BLISTER PACK in 1 BLISTER PACK / 10 TABLET in 1 BLISTER PACK", "package_ndc": "70183-221-31", "marketing_start_date": "20231201"}], "brand_name": "INPEFA", "product_id": "70183-221_cd790640-aade-49e0-a549-6eac00d3efc2", "dosage_form": "TABLET", "pharm_class": ["P-Glycoprotein Inhibitors [MoA]", "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]", "Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "product_ndc": "70183-221", "generic_name": "sotagliflozin", "labeler_name": "Lexicon Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INPEFA", "active_ingredients": [{"name": "SOTAGLIFLOZIN", "strength": "200 mg/1"}], "application_number": "NDA216203", "marketing_category": "NDA", "marketing_start_date": "20230526", "listing_expiration_date": "20271231"}