Prescription drug · NDA
Blujepa (Gepotidacin) NDC 0173-0922
Gepotidacin mesylate 750 mg/1 · Tablet, Film coated · Oral · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0922-38 | 00173092238 | 8 TABLET, FILM COATED in 1 BOTTLE (0173-0922-38)Marketed from Dec 11, 2025 | |
| 0173-0922-45 | 00173092245 | 20 TABLET, FILM COATED in 1 BOTTLE (0173-0922-45)Marketed from Mar 25, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Blujepa
- Generic name (nonproprietary)
- gepotidacin
- Active ingredients
- Gepotidacin mesylate — 750 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- GlaxoSmithKline LLCNDC labeler code 0173
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 218230
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Topoisomerase 2 Inhibitors (Mechanism)Topoisomerase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 0173-0922_1cb00eb0-9123-4532-b49e-55b9265daf9eSPL ID 1cb00eb0-9123-4532-b49e-55b9265daf9eSPL set ID 80b57cfe-7819-4d95-a57d-014af42f118dRxCUI 2709218, 2709224UNII 5P7X0H2O6BUPC 0301730922458
- Pharmacologic class
- Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400173092238followed by a unit qualifier and the quantityPackage 00173-0922-38. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: • Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). ( 1.1 ) • Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety data for this indication. ( 1.2 , 6.1 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug…
Excerpt only. Read the full label for complete information.
About NDC 0173-0922
- What is NDC 0173-0922?
- 0173-0922 is the product NDC for Blujepa (gepotidacin), Gepotidacin mesylate 750 mg/1 tablet, film coated, listed with the FDA by GlaxoSmithKline LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Blujepa (Gepotidacin).
- What is the active ingredient?
- Gepotidacin mesylate.
- Who is the labeler?
- GlaxoSmithKline LLC, NDC labeler code 0173. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Blujepa?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.