bexagliflozin

Generic: bexagliflozin

Labeler: theracosbio, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name bexagliflozin
Generic Name bexagliflozin
Labeler theracosbio, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

bexagliflozin 20 mg/1

Manufacturer
TheracosBio, LLC

Identifiers & Regulatory

Product NDC 82381-2000
Product ID 82381-2000_8e571636-526b-4d31-a8ac-c19014a59f9c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA214373
Listing Expiration 2026-12-31
Marketing Start 2024-03-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 823812000
Hyphenated Format 82381-2000

Supplemental Identifiers

RxCUI
2637859
UNII
EY00JF42FV
NUI
N0000187059 N0000187058

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 bexagliflozin (source: ndc)
Generic Name bexagliflozin (source: ndc)
Application Number NDA214373 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (82381-2000-8)
  • 90 TABLET in 1 BOTTLE (82381-2000-9)
source: ndc

Packages (2)

82381-2000-8 30 TABLET in 1 BOTTLE (82381-2000-8) 82381-2000-9 90 TABLET in 1 BOTTLE (82381-2000-9)

Ingredients (1)

bexagliflozin (20 mg/1)

Linked Drug Pages (1)

Bexagliflozin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8e571636-526b-4d31-a8ac-c19014a59f9c", "openfda": {"nui": ["N0000187059", "N0000187058"], "unii": ["EY00JF42FV"], "rxcui": ["2637859"], "spl_set_id": ["7f0ad5d2-3509-4057-904c-d27993de7408"], "pharm_class_epc": ["Sodium-Glucose Cotransporter 2 Inhibitor [EPC]"], "pharm_class_moa": ["Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["TheracosBio, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (82381-2000-8)", "package_ndc": "82381-2000-8", "marketing_start_date": "20240319"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (82381-2000-9)", "package_ndc": "82381-2000-9", "marketing_start_date": "20240319"}], "brand_name": "Bexagliflozin", "product_id": "82381-2000_8e571636-526b-4d31-a8ac-c19014a59f9c", "dosage_form": "TABLET", "pharm_class": ["Sodium-Glucose Cotransporter 2 Inhibitor [EPC]", "Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "product_ndc": "82381-2000", "generic_name": "Bexagliflozin", "labeler_name": "TheracosBio, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bexagliflozin", "active_ingredients": [{"name": "BEXAGLIFLOZIN", "strength": "20 mg/1"}], "application_number": "NDA214373", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240319", "listing_expiration_date": "20261231"}