Home NDC 0173-0922 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218230-001 BLUJEPA GEPOTIDACIN MESYLATE EQ 750MG BASE TABLET / ORAL RLD, RS 2025-03-25
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218230-001 8389524 2029-02-12 U-4166 Drug substance, Drug product 2025-04-21 N218230-001 10702521 2035-08-20 U-4361 2025-12-23 N218230-001 11229646 2035-08-20 U-4361 2025-12-23 N218230-001 12528809 2042-12-13 U-4361 Drug substance, Drug product 2026-02-12 N218230-001 12528809 2042-12-13 U-4408 Drug substance, Drug product 2026-02-12
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N218230-001 I-978 2028-12-11 N218230-001 NCE 2030-03-25 N218230-001 GAIN 2035-03-25
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N218230-001 BLUJEPA EQ 750MG BASE TABLET / ORAL RLD, RS 2025-03-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218230-001 BLUJEPA EQ 750MG BASE TABLET / ORAL RLD, RS 2025-03-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218230-001 BLUJEPA EQ 750MG BASE TABLET / ORAL RLD, RS 2025-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218230-001 BLUJEPA EQ 750MG BASE TABLET / ORAL RLD, RS 2025-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218230-001 BLUJEPA EQ 750MG BASE TABLET / ORAL RLD, RS 2025-03-25 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218230-001 BLUJEPA EQ 750MG BASE TABLET / ORAL RLD, RS 2025-03-25 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N218230-001 8389524 2029-02-12 U-4166 Drug substance, Drug product 2025-04-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218230-001 10702521 2035-08-20 U-4361 2025-12-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218230-001 11229646 2035-08-20 U-4361 2025-12-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218230-001 12528809 2042-12-13 U-4361 Drug substance, Drug product 2026-02-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218230-001 12528809 2042-12-13 U-4408 Drug substance, Drug product 2026-02-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218230-001 8389524 2029-02-12 U-4166 Drug substance, Drug product 2025-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218230-001 10702521 2035-08-20 U-4361 2025-12-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218230-001 11229646 2035-08-20 U-4361 2025-12-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218230-001 12528809 2042-12-13 U-4361 Drug substance, Drug product 2026-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218230-001 12528809 2042-12-13 U-4408 Drug substance, Drug product 2026-02-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218230-001 8389524 2029-02-12 U-4166 Drug substance, Drug product 2025-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218230-001 10702521 2035-08-20 U-4361 2025-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218230-001 11229646 2035-08-20 U-4361 2025-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218230-001 8389524 2029-02-12 U-4166 Drug substance, Drug product 2025-04-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218230-001 8389524 2029-02-12 U-4166 Drug substance, Drug product 2025-04-21 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218230-001 8389524 2029-02-12 U-4166 Drug substance, Drug product 2025-04-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218230-001 10702521 2035-08-20 U-4361 2025-12-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218230-001 11229646 2035-08-20 U-4361 2025-12-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218230-001 12528809 2042-12-13 U-4361 Drug substance, Drug product 2026-02-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218230-001 12528809 2042-12-13 U-4408 Drug substance, Drug product 2026-02-12 a50c72e98297…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Blujepa
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GEPOTIDACIN MESYLATE 750 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5P7X0H2O6B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2709218 Internal RxNorm lookup 2709224 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0173-0922-38 Blujepa 8 in 1 BOTTLE TABLET, FILM COATED 8 3 0173-0922-45 Blujepa 20 in 1 BOTTLE TABLET, FILM COATED 20 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0173-0922 BLUJEPA (GEPOTIDACIN) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 1 Current NDC, 2 package rows 20250327_80b57cfe-7819-4d95-a57d-014af42f118d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0173-0922-38 00173092238 8 TABLET, FILM COATED in 1 BOTTLE (0173-0922-38) 2025-12-11 No No Current 0173-0922-45 00173092245 20 TABLET, FILM COATED in 1 BOTTLE (0173-0922-45) 2025-03-25 No No Current