Furosemide

Product NDC
55154-9582
11-digit product format
551549582
Labeler code
55154
Product ID
55154-9582_1e79b2a7-f1bb-433e-b1df-a5c3963cbd83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FUROSEMIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Cardinal Health 107, LLC
Application
NDA018902
Marketing category
NDA
Marketing start
2000-07-12
Substance
FUROSEMIDE
Active strength
10 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 42.

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
N018902-001FUROSEMIDEFUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N018902-001AP

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-223f01610625f2…
2019-09-15 20:21 UTC2019-09N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22b00525d2431f…
2019-07-19 19:46 UTC2019-07N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-223f0d92c62455…
2023-05-13 08:27 UTC2023-05N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22053a50430f4f…
2023-01-26 05:58 UTC2023-01N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018902-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1984-05-22e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018902-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018902-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018902-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018902-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018902-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018902-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018902-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018902-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018902-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018902-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018902-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018902-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018902-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018902-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018902-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018902-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018902-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018902-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018902-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018902-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018902-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018902-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N018902-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018902-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018902-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018902-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N018902-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018902-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018902-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018902-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018902-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018902-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018902-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018902-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018902-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018902-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018902-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018902-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018902-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018902-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Furosemide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FUROSEMIDE10 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1719291Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d75ba8bd-9494-4306-8443-9c1a90992dd5Available 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
55154-9582-5Furosemide4 mL in 1 VIALINJECTION, SOLUTION45
55154-9582-5Furosemide5 in 1 BAGINJECTION, SOLUTION55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-9582FUROSEMIDE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]4Current NDC, Legacy NDC, 2 package rows20241101_d75ba8bd-9494-4306-8443-9c1a90992dd5.zip

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FurosemideFUROSEMIDECardinal Health 107, LLC42478c55-9056-487a-89a9-d36904beea122026-06-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 018902
application number: NDA018902
FurosemideFUROSEMIDEPhlow Corporation08a44bdd-028d-41af-9d4e-70971b0bcc4e2026-01-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 018902
application number: NDA018902
FurosemideFUROSEMIDECardinal Health 107, LLCd75ba8bd-9494-4306-8443-9c1a90992dd52025-10-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 018902
application number: NDA018902
ndc (product): 55154-9582
FurosemideFUROSEMIDEFresenius Kabi USA, LLCc794c95a-654e-48fe-9596-201fc122ff752024-12-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 018902
application number: NDA018902
FurosemideFUROSEMIDEFresenius Kabi USA, LLC3747bbcd-783d-4baa-bb5b-b6827bf390e32024-12-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 018902
application number: NDA018902
FUROSEMIDEFUROSEMIDEHF Acquisition Co LLC, DBA HealthFirstc5db4434-0b47-038c-e053-2995a90ad7fe2024-01-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 018902
application number: NDA018902
FUROSEMIDEFUROSEMIDEHF Acquisition Co LLC, DBA HealthFirstc5db2be1-088f-1110-e053-2a95a90acac82024-01-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 018902
application number: NDA018902
FUROSEMIDEFUROSEMIDEHF Acquisition Co LLC, DBA HealthFirstc5d9b063-e3fe-ec2f-e053-2995a90ab3f22021-06-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 018902
application number: NDA018902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719291furosemide 40 MG in 4 ML InjectionPSNd75ba8bd-9494-4306-8443-9c1a90992dd55
17192914 ML furosemide 10 MG/ML InjectionSCDd75ba8bd-9494-4306-8443-9c1a90992dd55
1719291furosemide 40 MG per 4 ML InjectionSYd75ba8bd-9494-4306-8443-9c1a90992dd55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-9582-5551549582055 VIAL in 1 BAG (55154-9582-5) / 4 mL in 1 VIAL5 vial2000-07-120000-00-00NoNoCurrent