Furosemide

Product NDC
0404-9863
11-digit product format
004049863
Labeler code
0404
Product ID
0404-9863_8bcc9b7c-c32c-4a32-bd43-236058d8ce82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA202747
Marketing category
ANDA
Marketing start
2022-01-10
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 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
A202747-001FUROSEMIDEFUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202747-001AP

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-273f01610625f2…
2019-09-15 20:21 UTC2019-09A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202747-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAPRS2014-01-27cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202747-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202747-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202747-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202747-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202747-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202747-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202747-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202747-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202747-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202747-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202747-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202747-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202747-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202747-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202747-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202747-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202747-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202747-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202747-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202747-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202747-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A202747-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202747-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202747-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202747-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A202747-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202747-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202747-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202747-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202747-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202747-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202747-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202747-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202747-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202747-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202747-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202747-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202747-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202747-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202747-001AP1cb3db0bc1861…

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
d8407b0e-7838-4ab6-b9dd-1f7ecf1e0a17Available 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
0404-9863-04Furosemide1 in 1 BAGINJECTION, SOLUTION15
0404-9863-04Furosemide4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9863FUROSEMIDE INJECTION, SOLUTION [HENRY SCHEIN, INC.]4Current NDC, Legacy NDC, 2 package rows20241016_d8407b0e-7838-4ab6-b9dd-1f7ecf1e0a17.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, LLC2590ebb6-ce2a-4e23-9244-e54e3010d4882026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202747
application number: ANDA202747
FUROSEMIDEFUROSEMIDECivica, Inc.7ecaa5af-d186-4380-b105-e7e528f75cc72025-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202747
application number: ANDA202747
FUROSEMIDEFUROSEMIDEHenry Schein, Inc.a9853417-0442-4f53-9543-e0749bc3c80d2025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202747
application number: ANDA202747
FurosemideFUROSEMIDEHenry Schein, Inc.d8407b0e-7838-4ab6-b9dd-1f7ecf1e0a172025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202747
application number: ANDA202747
ndc (product): 0404-9863
FUROSEMIDEFUROSEMIDEREMEDYREPACK INC.ab1a7e16-f746-41af-8faf-b69d3ffd62ba2025-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202747
application number: ANDA202747
FUROSEMIDEFUROSEMIDEBaxter Healthcare Corporationc71371a7-75c5-45b8-b762-8d782d4c71bc2025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202747
application number: ANDA202747
FUROSEMIDEFUROSEMIDEMedical Purchasing Solutions, LLC6a2235e8-d488-2d43-e053-2991aa0aa4852023-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202747
application number: ANDA202747
FUROSEMIDEFUROSEMIDEMedical Purchasing Solutions, LLC6947af02-f50b-7f9c-e053-2a91aa0a45cd2023-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202747
application number: ANDA202747

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719291furosemide 40 MG in 4 ML InjectionPSNd8407b0e-7838-4ab6-b9dd-1f7ecf1e0a175
17192914 ML furosemide 10 MG/ML InjectionSCDd8407b0e-7838-4ab6-b9dd-1f7ecf1e0a175
1719291furosemide 40 MG per 4 ML InjectionSYd8407b0e-7838-4ab6-b9dd-1f7ecf1e0a175

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9863-04004049863041 VIAL, SINGLE-DOSE in 1 BAG (0404-9863-04) / 4 mL in 1 VIAL, SINGLE-DOSE2022-01-100000-00-00NoNoCurrent