blujepa

Generic: gepotidacin

Labeler: glaxosmithkline llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name blujepa
Generic Name gepotidacin
Labeler glaxosmithkline llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

gepotidacin mesylate 750 mg/1

Manufacturer
GlaxoSmithKline LLC

Identifiers & Regulatory

Product NDC 0173-0922
Product ID 0173-0922_1cb00eb0-9123-4532-b49e-55b9265daf9e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA218230
Listing Expiration 2027-12-31
Marketing Start 2025-03-25

Pharmacologic Class

Classes
cholinesterase inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] p-glycoprotein inhibitors [moa] topoisomerase 2 inhibitors [moa] topoisomerase 4 inhibitors [moa] triazaacenaphthylene bacterial type ii topoisomerase inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01730922
Hyphenated Format 0173-0922

Supplemental Identifiers

RxCUI
2709218 2709224
UPC
0301730922458
UNII
5P7X0H2O6B

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 blujepa (source: ndc)
Generic Name gepotidacin (source: ndc)
Application Number NDA218230 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 8 TABLET, FILM COATED in 1 BOTTLE (0173-0922-38)
  • 20 TABLET, FILM COATED in 1 BOTTLE (0173-0922-45)
source: ndc

Packages (2)

0173-0922-38 8 TABLET, FILM COATED in 1 BOTTLE (0173-0922-38) 0173-0922-45 20 TABLET, FILM COATED in 1 BOTTLE (0173-0922-45)

Ingredients (1)

gepotidacin mesylate (750 mg/1)

Linked Drug Pages (1)

Blujepa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1cb00eb0-9123-4532-b49e-55b9265daf9e", "openfda": {"upc": ["0301730922458"], "unii": ["5P7X0H2O6B"], "rxcui": ["2709218", "2709224"], "spl_set_id": ["80b57cfe-7819-4d95-a57d-014af42f118d"], "manufacturer_name": ["GlaxoSmithKline LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 TABLET, FILM COATED in 1 BOTTLE (0173-0922-38)", "package_ndc": "0173-0922-38", "marketing_start_date": "20251211"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (0173-0922-45)", "package_ndc": "0173-0922-45", "marketing_start_date": "20250325"}], "brand_name": "Blujepa", "product_id": "0173-0922_1cb00eb0-9123-4532-b49e-55b9265daf9e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Topoisomerase 2 Inhibitors [MoA]", "Topoisomerase 4 Inhibitors [MoA]", "Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor [EPC]"], "product_ndc": "0173-0922", "generic_name": "gepotidacin", "labeler_name": "GlaxoSmithKline LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Blujepa", "active_ingredients": [{"name": "GEPOTIDACIN MESYLATE", "strength": "750 mg/1"}], "application_number": "NDA218230", "marketing_category": "NDA", "marketing_start_date": "20250325", "listing_expiration_date": "20271231"}