Home NDC 71767-111-01 FUROSCIX
Product NDC 71767-111
Requested package NDC 71767-111-01
11-digit product format 717670111
Labeler code 71767
Product ID 71767-111_557b4a8d-be6d-8d78-e063-6294a90a0ace
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name furosemide
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler scPharmaceuticals Inc., a wholly owned subsidiary of MannKind Corporation
Application NDA209988
Marketing category NDA
Marketing start 2026-07-27
Substance FUROSEMIDE
Active strength 80 mg/mL
Pharmacologic classes Increased Diuresis at Loop of Henle [PE]; Loop Diuretic [EPC]
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N209988-001 FUROSCIX FUROSEMIDE 80MG/10ML (8MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-10-07
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209988-001 10272064 2034-04-03 Drug product 2022-11-02 N209988-001 11433044 2034-04-03 U-3462 2022-11-02 N209988-001 12370168 2034-04-03 U-3462 Drug product 2025-08-22 N209988-001 9884039 2034-04-03 U-3462 2022-11-02
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 2026-08-01 22:54:32 2026-06 N209988-001 FUROSCIX 80MG/10ML (8MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-10-07 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 2026-08-01 22:54:32 2026-06 N209988-001 10272064 2034-04-03 Drug product 2022-11-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N209988-001 11433044 2034-04-03 U-3462 2022-11-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N209988-001 12370168 2034-04-03 U-3462 Drug product 2025-08-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209988-001 9884039 2034-04-03 U-3462 2022-11-02 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base FUROSCIX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FUROSEMIDE 80 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 2621022 Internal RxNorm lookup 2621028 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Status 71767-111-01 71767011101 1 SYRINGE, GLASS in 1 CARTON (71767-111-01) / 1 mL in 1 SYRINGE, GLASS 2026-07-27 0 Current