Home NDC 81137-001-35 LASIX ONYU
Product NDC 81137-001
Requested package NDC 81137-001-35
11-digit product format 811370001
Labeler code 81137
Product ID 81137-001_a67aa830-538d-4920-ac7e-9b4418362473
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name furosemide
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler SQ Innovation, Inc.
Application NDA217294
Marketing category NDA
Marketing start 2025-12-01
Substance FUROSEMIDE
Active strength 30 mg/mL
Pharmacologic classes Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
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 N217294-001 LASIX ONYU FUROSEMIDE 80MG/2.67ML (30MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-10-07
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217294-001 11246851 2040-01-03 U-4576 Drug product 2026-07-22 N217294-001 12318363 2040-01-03 Drug product 2026-07-22 N217294-001 12403120 2042-01-10 U-4576 Drug product 2026-07-22
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 N217294-001 LASIX ONYU 80MG/2.67ML (30MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-10-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217294-001 LASIX ONYU 80MG/2.67ML (30MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-10-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217294-001 LASIX ONYU 80MG/2.67ML (30MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217294-001 LASIX ONYU 80MG/2.67ML (30MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-10-07 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217294-001 LASIX ONYU 80MG/2.67ML (30MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-10-07 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 N217294-001 11246851 2040-01-03 U-4576 Drug product 2026-07-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217294-001 12318363 2040-01-03 Drug product 2026-07-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217294-001 12403120 2042-01-10 U-4576 Drug product 2026-07-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217294-001 11246851 2040-01-03 U-4576 Drug product 2026-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217294-001 12318363 2040-01-03 Drug product 2026-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217294-001 12403120 2042-01-10 U-4576 Drug product 2026-07-22 caaa826d4ba7…
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 LASIX ONYU
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FUROSEMIDE 30 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7LXU5N7ZO5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2725542 Internal RxNorm lookup 2725546 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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 81137-001-35 81137000135 3 CARTON in 1 KIT (81137-001-35) / 1 CARTRIDGE in 1 CARTON / 2.67 mL in 1 CARTRIDGE 3 carton 2026-06-15 No No Current