FUROSEMIDE

Product NDC
51662-1227
11-digit product format
516621227
Labeler code
51662
Product ID
51662-1227_1031ee8d-58d0-6149-e063-6294a90a4f58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FUROSEMIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA018667
Marketing category
NDA
Marketing start
2018-09-14
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 43.

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
N018667-001FUROSEMIDEFUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018667-001AP

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-2884e616aacf4f…
2026-08-18 06:07:402026-07N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-283f01610625f2…
2019-09-15 20:21 UTC2019-09N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N018667-001AP184e616aacf4f…
2026-08-18 06:07:402026-07N018667-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018667-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018667-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018667-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018667-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018667-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018667-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018667-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018667-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018667-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018667-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018667-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018667-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018667-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018667-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018667-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018667-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018667-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018667-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018667-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018667-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018667-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N018667-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018667-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018667-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018667-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N018667-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018667-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018667-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018667-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018667-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018667-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018667-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018667-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018667-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018667-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018667-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018667-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018667-001AP1f41ea6bd6efb…

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
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
1719290Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
75d68f19-424c-109e-e053-2991aa0ac857Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51662-1227-12020-02-07C16284748780-19d75b9d0-bc05-f424-e053-dadaa90a57ceFUROSEMIDE INJ., USP 20mg/2mL (10mg/mL) VIAL
51662-1227-12020-01-31C16284748780-19d75b9d0-bc05-f424-e053-dadaa90a57ceFUROSEMIDE INJ., USP 20mg/2mL (10mg/mL) VIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1227-1FUROSEMIDE2 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION27
51662-1227-2FUROSEMIDE1 mL in 1 POUCHINJECTION, SOLUTION17
51662-1227-3FUROSEMIDE25 in 1 CASEINJECTION, SOLUTION257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1227FUROSEMIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]7Current NDC, Legacy NDC, 3 package rows20240131_75d68f19-424c-109e-e053-2991aa0ac857.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
FurosemideFUROSEMIDEMedical Purchasing Solutions, LLC58cc1e38-6000-1489-e063-6394a90a59782026-08-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 018667
application number: NDA018667
FUROSEMIDEFUROSEMIDEHF Acquisition Co LLC, DBA HealthFirst75d5611a-f9e0-1841-e053-2991aa0af4152026-06-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 018667
application number: NDA018667
FurosemideFUROSEMIDECardinal Health 107, LLC71b48f4d-9936-448c-9e3a-33f1182e10392026-05-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 018667
application number: NDA018667
FurosemideFUROSEMIDEHospira, Inc.39fd32f2-6bb7-4a65-d298-e48d26bc80c72026-05-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 018667
application number: NDA018667
FUROSEMIDEFUROSEMIDEHospira, Inc.aaced7a8-c3d7-4d66-8c07-aa407b8b3f352026-05-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 018667
application number: NDA018667
FurosemideFUROSEMIDECardinal Health 107, LLC8e0bac29-5a8b-4d4e-93b3-2e21eb3b06502026-05-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 018667
application number: NDA018667
FUROSEMIDEFUROSEMIDEHF Acquisition Co LLC, DBA HealthFirst75d68f19-424c-109e-e053-2991aa0ac8572024-01-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 018667
application number: NDA018667
ndc (product): 51662-1227
FUROSEMIDEFUROSEMIDEHF Acquisition Co LLC, DBA HealthFirst7b9af6a4-e1da-eb95-e053-2991aa0a031d2024-01-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 018667
application number: NDA018667

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719290furosemide 20 MG in 2 ML InjectionPSN75d68f19-424c-109e-e053-2991aa0ac8577
17192902 ML furosemide 10 MG/ML InjectionSCD75d68f19-424c-109e-e053-2991aa0ac8577
1719290furosemide 20 MG per 2 ML InjectionSY75d68f19-424c-109e-e053-2991aa0ac8577

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1227-1516621227012 mL in 1 VIAL, SINGLE-USE (51662-1227-1) 2 ml2018-09-140000-00-00NoNoCurrent
51662-1227-2516621227021 mL in 1 POUCH1 mlHistorical
51662-1227-35166212270325 POUCH in 1 CASE (51662-1227-3) / 1 mL in 1 POUCH (51662-1227-2) 25 pouch2020-10-270000-00-00NoNoCurrent