Furosemide

Product NDC
16729-501
11-digit product format
167290501
Labeler code
16729
Product ID
16729-501_1cfab300-d796-6a68-e063-6394a90a73f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Accord Healthcare, Inc.
Application
ANDA070017
Marketing category
ANDA
Marketing start
2021-04-21
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
A070017-001FUROSEMIDEFUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070017-001AP

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 UTC2026-02A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1986-12-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1986-12-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1986-12-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1986-12-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1986-12-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1986-12-153f01610625f2…
2019-09-15 20:21 UTC2019-09A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1986-12-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1986-12-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070017-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1986-12-15cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A070017-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070017-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070017-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070017-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070017-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070017-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070017-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070017-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070017-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070017-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070017-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070017-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070017-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070017-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070017-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070017-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070017-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A070017-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070017-001AP1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070017-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070017-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070017-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070017-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070017-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070017-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070017-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A070017-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A070017-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070017-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070017-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070017-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070017-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A070017-001AP1a50c72e98297…

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1719286Internal RxNorm lookup
1719290Internal RxNorm lookup
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
f6f64972-714c-4ee9-8a5e-9ffcab41a73bAvailable 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
16729-501-43Furosemide10 in 1 CARTONINJECTION105
16729-501-64Furosemide4 mL in 1 VIAL, SINGLE-DOSEINJECTION45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-501-43ML - Milliliter16729-50148e9f1af-ad23-4932-abc3-49c4647b1ea912021-05-05
16729-501-64ML - Milliliter16729-50118eee585-7f53-488a-93be-d0ea24b5269e12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-501FUROSEMIDE INJECTION [ACCORD HEALTHCARE, INC.]5Current NDC, Legacy NDC, 2 package rows20240712_f6f64972-714c-4ee9-8a5e-9ffcab41a73b.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FurosemideFUROSEMIDEAccord Healthcare, Inc.f6f64972-714c-4ee9-8a5e-9ffcab41a73b2024-07-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070017
application number: ANDA070017
ndc (product): 16729-501
FurosemideFUROSEMIDEMedical Purchasing Solutions, LLCd8a064cc-c741-8b80-e053-2a95a90a364c2023-05-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070017
application number: ANDA070017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719286furosemide 100 MG in 10 ML InjectionPSNf6f64972-714c-4ee9-8a5e-9ffcab41a73b5
1719290furosemide 20 MG in 2 ML InjectionPSNf6f64972-714c-4ee9-8a5e-9ffcab41a73b5
1719291furosemide 40 MG in 4 ML InjectionPSNf6f64972-714c-4ee9-8a5e-9ffcab41a73b5
171928610 ML furosemide 10 MG/ML InjectionSCDf6f64972-714c-4ee9-8a5e-9ffcab41a73b5
17192902 ML furosemide 10 MG/ML InjectionSCDf6f64972-714c-4ee9-8a5e-9ffcab41a73b5
17192914 ML furosemide 10 MG/ML InjectionSCDf6f64972-714c-4ee9-8a5e-9ffcab41a73b5
1719286furosemide 100 MG per 10 ML InjectionSYf6f64972-714c-4ee9-8a5e-9ffcab41a73b5
1719290furosemide 20 MG per 2 ML InjectionSYf6f64972-714c-4ee9-8a5e-9ffcab41a73b5
1719291furosemide 40 MG per 4 ML InjectionSYf6f64972-714c-4ee9-8a5e-9ffcab41a73b5
1719291furosemide 40 MG in 4 ML InjectionPSNd8a064cc-c741-8b80-e053-2a95a90a364c4
17192914 ML furosemide 10 MG/ML InjectionSCDd8a064cc-c741-8b80-e053-2a95a90a364c4
1719291furosemide 40 MG per 4 ML InjectionSYd8a064cc-c741-8b80-e053-2a95a90a364c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-501-431672905014310 VIAL, SINGLE-DOSE in 1 CARTON (16729-501-43) / 4 mL in 1 VIAL, SINGLE-DOSE (16729-501-64) 2021-04-210000-00-00NoNoCurrent
16729-501-64167290501644 mL in 1 VIAL, SINGLE-DOSE4 mlHistorical