FDA.reportPublic FDA data

Blujepa

Product NDC
0173-0922
11-digit product format
001730922
Labeler code
0173
Product ID
0173-0922_1cb00eb0-9123-4532-b49e-55b9265daf9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gepotidacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
GlaxoSmithKline LLC
Application
NDA218230
Marketing category
NDA
Marketing start
2025-03-25
Substance
GEPOTIDACIN MESYLATE
Active strength
750 mg/1
Pharmacologic 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]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Blujepa
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GEPOTIDACIN MESYLATE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5P7X0H2O6B
Rxcui2709218, 2709224

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89ed0c36-14bd-40d3-a4cb-f04aa63d5345Product name120260108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0173-0922-38Blujepa8 in 1 BOTTLETABLET, FILM COATED83
0173-0922-45Blujepa20 in 1 BOTTLETABLET, FILM COATED203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0922-45EA - Each0173-0922e3cbc4ba-2389-4cbe-9fad-b6adaed5065c12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0922BLUJEPA (GEPOTIDACIN) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]1Current NDC, 2 package rows20250327_80b57cfe-7819-4d95-a57d-014af42f118d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2709224BLUJEPA 750 MG Oral TabletPSN80b57cfe-7819-4d95-a57d-014af42f118d3
2709218gepotidacin 750 MG Oral TabletPSN80b57cfe-7819-4d95-a57d-014af42f118d3
2709224gepotidacin 750 MG Oral Tablet [Blujepa]SBD80b57cfe-7819-4d95-a57d-014af42f118d3
2709218gepotidacin 750 MG Oral TabletSCD80b57cfe-7819-4d95-a57d-014af42f118d3
2709224Blujepa 750 MG (equivalent to gepotidacin mesylate dihydrate 970.96 MG) Oral TabletSY80b57cfe-7819-4d95-a57d-014af42f118d3
2709224Blujepa 750 MG Oral TabletSY80b57cfe-7819-4d95-a57d-014af42f118d3
2709218gepotidacin 750 MG (equivalent to gepotidacin mesylate dihydrate 970.96 MG) Oral TabletSY80b57cfe-7819-4d95-a57d-014af42f118d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0173-0922-38001730922388 TABLET, FILM COATED in 1 BOTTLE (0173-0922-38) 2025-12-11NoNoCurrent
0173-0922-450017309224520 TABLET, FILM COATED in 1 BOTTLE (0173-0922-45) 2025-03-25NoNoCurrent