FUROSCIX

Product NDC
71767-100
Requested package NDC
71767-100-01
11-digit product format
717670100
Labeler code
71767
Product ID
71767-100_46518b53-5ca8-c68b-e063-6394a90a4150
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
furosemide injection 80 mg/ 10 mL
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
scPharmaceuticals Inc.
Application
NDA209988
Marketing category
NDA
Marketing start
2022-11-14
Substance
FUROSEMIDE
Active strength
8 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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209988-001FUROSCIXFUROSEMIDE80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-07

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209988-001102720642034-04-03Drug product2022-11-02
N209988-001114330442034-04-03U-34622022-11-02
N209988-001123701682034-04-03U-3462Drug product2025-08-22
N209988-00198840392034-04-03U-34622022-11-02

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-07a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N209988-001102720642034-04-03Drug product2022-11-02a50c72e98297…
2026-08-01 22:54:322026-06N209988-001114330442034-04-03U-34622022-11-02a50c72e98297…
2026-08-01 22:54:322026-06N209988-001123701682034-04-03U-3462Drug product2025-08-22a50c72e98297…
2026-08-01 22:54:322026-06N209988-00198840392034-04-03U-34622022-11-02a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FUROSCIXFUROSEMIDE INJECTION 80 MG/ 10 MLscPharmaceuticals Inc., a wholly owned subsidiary of MannKind Corporationeac958dd-8d43-e44e-e053-2995a90a4d5e2026-07-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 209988
application number: NDA209988
ndc (package): 71767-100-01
ndc (product): 71767-100
ndc11 (package): 71767010001

Additional Listing Data#

Finished product
Yes
Brand name base
FUROSCIX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FUROSEMIDE8 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7LXU5N7ZO5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2621022Internal RxNorm lookup
2621028Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
eac958dd-8d43-e44e-e053-2995a90a4d5eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d80d3aff-3a63-4d7b-a2be-fd9388b04330Product name920250806
9061e89f-9c86-4196-b34b-886fc1673cc4Product name120140821

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71767-100-01FUROSCIX1 in 1 KITINJECTION118
71767-100-01FUROSCIX1 in 1 CARTONINJECTION118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71767-100-01EA - Each71767-10073c105f1-e6c1-4368-a671-be5c09e2954012022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71767-100FUROSCIX (FUROSEMIDE INJECTION 80 MG/ 10 ML) INJECTION [SCPHARMACEUTICALS INC.]16Current NDC, Legacy NDC, 2 package rows20250315_eac958dd-8d43-e44e-e053-2995a90a4d5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2621028Furoscix 80 MG in 10 ML CartridgePSNeac958dd-8d43-e44e-e053-2995a90a4d5e18
2621022furosemide 80 MG in 10 ML CartridgePSNeac958dd-8d43-e44e-e053-2995a90a4d5e18
262102810 ML furosemide 8 MG/ML Cartridge [Furoscix]SBDeac958dd-8d43-e44e-e053-2995a90a4d5e18
262102210 ML furosemide 8 MG/ML CartridgeSCDeac958dd-8d43-e44e-e053-2995a90a4d5e18
262102810 ML Furoscix 8 MG/ML CartridgeSYeac958dd-8d43-e44e-e053-2995a90a4d5e18
2621028Furoscix 8 MG/ML per 10 ML CartridgeSYeac958dd-8d43-e44e-e053-2995a90a4d5e18
2621028Furoscix 80 MG per 10 ML CartridgeSYeac958dd-8d43-e44e-e053-2995a90a4d5e18
2621022furosemide 8 MG/ML per 10 ML CartridgeSYeac958dd-8d43-e44e-e053-2995a90a4d5e18
2621022furosemide 80 MG per 10 ML CartridgeSYeac958dd-8d43-e44e-e053-2995a90a4d5e18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71767-100-01717670100011 CARTON in 1 KIT (71767-100-01) / 1 CARTRIDGE in 1 CARTON / 10 mL in 1 CARTRIDGE1 carton2022-11-140000-00-00NoNoCurrent