FDA.reportPublic FDA data

FUROSCIX

Product NDC
71767-111
Requested package NDC
71767-111-01
11-digit product format
717670111
Labeler code
71767
Product ID
71767-111_57ef4d44-0cc5-db23-e063-6294a90a50cc
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]
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 · 2 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
N209988-002FUROSCIX READYFLOW (AUTOINJECTOR)FUROSEMIDE80MG/ML (80MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-07-23

Orange Book patents#

Current patent rows page 1 of 1 · 14 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
N209988-002114977552040-01-30Drug product2026-08-21
N209988-002115595352040-01-30Drug product2026-08-21
N209988-002115714342040-01-30Drug product2026-08-21
N209988-002119985552040-01-30U-4589Drug product2026-08-21
N209988-002120487092040-01-30U-4588Drug product2026-08-21
N209988-002124911932040-01-30U-4588Drug product2026-08-21
N209988-002124911942040-01-30U-4588Drug product2026-08-21
N209988-002124911952040-01-30U-4588Drug product2026-08-21
N209988-002124911962040-01-30U-4588Drug product2026-08-21
N209988-002124911972040-01-30U-4588Drug product2026-08-21

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
2026-09-14 22:38:342026-08N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-0784e616aacf4f…
2026-09-14 22:38:342026-08N209988-002FUROSCIX READYFLOW (AUTOINJECTOR)80MG/ML (80MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-07-2384e616aacf4f…
2026-08-18 06:07:402026-07N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209988-002FUROSCIX READYFLOW (AUTOINJECTOR)80MG/ML (80MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-07-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-078072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-073f0d92c62455…
2023-05-13 08:27 UTC2023-05N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-07053a50430f4f…
2023-01-26 05:58 UTC2023-01N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-073a93d1ddd44b…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N209988-001FUROSCIX80MG/10ML (8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-07a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N209988-001102720642034-04-03Drug product2022-11-0284e616aacf4f…
2026-09-14 22:38:342026-08N209988-001114330442034-04-03U-34622022-11-0284e616aacf4f…
2026-09-14 22:38:342026-08N209988-001123701682034-04-03U-3462Drug product2025-08-2284e616aacf4f…
2026-09-14 22:38:342026-08N209988-00198840392034-04-03U-34622022-11-0284e616aacf4f…
2026-09-14 22:38:342026-08N209988-002114977552040-01-30Drug product2026-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N209988-002115595352040-01-30Drug product2026-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N209988-002115714342040-01-30Drug product2026-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N209988-002119985552040-01-30U-4589Drug product2026-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N209988-002120487092040-01-30U-4588Drug product2026-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N209988-002124911932040-01-30U-4588Drug product2026-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N209988-002124911942040-01-30U-4588Drug product2026-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N209988-002124911952040-01-30U-4588Drug product2026-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N209988-002124911962040-01-30U-4588Drug product2026-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N209988-002124911972040-01-30U-4588Drug product2026-08-2184e616aacf4f…
2026-08-18 06:07:402026-07N209988-001102720642034-04-03Drug product2022-11-02caaa826d4ba7…
2026-08-18 06:07:402026-07N209988-001114330442034-04-03U-34622022-11-02caaa826d4ba7…
2026-08-18 06:07:402026-07N209988-001123701682034-04-03U-3462Drug product2025-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07N209988-00198840392034-04-03U-34622022-11-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209988-001102720642034-04-03Drug product2022-11-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209988-001114330442034-04-03U-34622022-11-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209988-001123701682034-04-03U-3462Drug product2025-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209988-00198840392034-04-03U-34622022-11-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209988-001102720642034-04-03Drug product2022-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209988-001114330442034-04-03U-34622022-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209988-001123701682034-04-03U-3462Drug product2025-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209988-00198840392034-04-03U-34622022-11-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N209988-001102720642034-04-03Drug product2022-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209988-001114330442034-04-03U-34622022-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209988-00198840392034-04-03U-34622022-11-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209988-001102720642034-04-03Drug product2022-11-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209988-001114330442034-04-03U-34622022-11-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209988-00198840392034-04-03U-34622022-11-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209988-001102720642034-04-03Drug product2022-11-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209988-001114330442034-04-03U-34622022-11-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209988-00198840392034-04-03U-34622022-11-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209988-001102720642034-04-03Drug product2022-11-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209988-001114330442034-04-03U-34622022-11-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209988-00198840392034-04-03U-34622022-11-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209988-001102720642034-04-03Drug product2022-11-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209988-001114330442034-04-03U-34622022-11-022680178bc6a6…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209988-001NP2025-10-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N209988-001NP2025-10-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209988-001NP2025-10-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209988-001NP2025-10-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209988-001NP2025-10-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209988-001NP2025-10-072680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209988-001NP2025-10-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209988-001NP2025-10-07d06236e962d9…

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
FUROSCIX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FUROSEMIDE80 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2621022Internal RxNorm lookup
2621028Internal RxNorm lookup
2747765Internal RxNorm lookup
2747769Internal 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

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.

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-e053-2995a90a4d5e2026-07-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 209988
application number: NDA209988
ndc (package): 71767-111-01
ndc (product): 71767-111
ndc11 (package): 71767011101

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 formatDescriptionMarketing startSampleExclude flagStatus
71767-111-01717670111011 SYRINGE, GLASS in 1 CARTON (71767-111-01) / 1 mL in 1 SYRINGE, GLASS2026-07-27NoNoCurrent