Home NDC 68547-915 NUZOLVENCE
Product NDC 68547-915
11-digit product format 685470915
Labeler code 68547
Product ID 68547-915_1835ee35-6c63-46c0-856f-6205e76af7b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zoliflodacin
Dosage form FOR SUSPENSION
Route ORAL
Labeler La Jolla Pharmaceutical Company
Application NDA219491
Marketing category NDA
Marketing start 2026-04-01
Substance ZOLIFLODACIN
Active strength 3 g/1
NDC exclude flag No
Listing certified through 2026-12-31
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 N219491-001 NUZOLVENCE ZOLIFLODACIN 3GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2025-12-12
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219491-001 9040528 2029-10-13 U-4369 2026-01-09 N219491-001 8658641 2030-06-20 Drug substance 2026-01-09 N219491-001 8889671 2034-01-21 U-4369 Drug substance 2026-01-09 N219491-001 9187495 2034-01-21 U-4369 Drug substance 2026-01-09 N219491-001 9540394 2034-01-21 U-4369 2026-01-09 N219491-001 9839641 2034-01-21 U-4369 2026-01-09
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N219491-001 NCE 2030-12-12 N219491-001 GAIN 2035-12-12
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 N219491-001 NUZOLVENCE 3GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2025-12-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219491-001 NUZOLVENCE 3GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2025-12-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219491-001 NUZOLVENCE 3GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2025-12-12 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219491-001 NUZOLVENCE 3GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2025-12-12 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 N219491-001 9040528 2029-10-13 U-4369 2026-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219491-001 8658641 2030-06-20 Drug substance 2026-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219491-001 8889671 2034-01-21 U-4369 Drug substance 2026-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219491-001 9187495 2034-01-21 U-4369 Drug substance 2026-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219491-001 9540394 2034-01-21 U-4369 2026-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219491-001 9839641 2034-01-21 U-4369 2026-01-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219491-001 9040528 2029-10-13 U-4369 2026-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219491-001 8658641 2030-06-20 Drug substance 2026-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219491-001 8889671 2034-01-21 U-4369 Drug substance 2026-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219491-001 9187495 2034-01-21 U-4369 Drug substance 2026-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219491-001 9540394 2034-01-21 U-4369 2026-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219491-001 9839641 2034-01-21 U-4369 2026-01-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219491-001 9040528 2029-10-13 U-4369 2026-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219491-001 8658641 2030-06-20 Drug substance 2026-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219491-001 8889671 2034-01-21 U-4369 Drug substance 2026-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219491-001 9187495 2034-01-21 U-4369 Drug substance 2026-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219491-001 9540394 2034-01-21 U-4369 2026-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219491-001 9839641 2034-01-21 U-4369 2026-01-09 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219491-001 9040528 2029-10-13 U-4369 2026-01-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219491-001 8658641 2030-06-20 Drug substance 2026-01-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219491-001 8889671 2034-01-21 U-4369 Drug substance 2026-01-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219491-001 9187495 2034-01-21 U-4369 Drug substance 2026-01-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219491-001 9540394 2034-01-21 U-4369 2026-01-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219491-001 9839641 2034-01-21 U-4369 2026-01-09 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 NUZOLVENCE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZOLIFLODACIN 3 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FWL2263R77 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2739783 Internal RxNorm lookup 2739789 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 68547-915-10 NUZOLVENCE 1 in 1 CARTON FOR SUSPENSION 1 3 68547-915-10 NUZOLVENCE 1 in 1 PACKET FOR SUSPENSION 1 3
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 Units Marketing start Sample Exclude flag Status 68547-915-10 68547091510 1 PACKET in 1 CARTON (68547-915-10) / 1 FOR SUSPENSION in 1 PACKET 1 packet 2026-04-01 No No Current