Furosemide

Product NDC
70121-1076
11-digit product format
701211076
Labeler code
70121
Product ID
70121-1076_3dc93fba-902b-4673-9f60-9bd4a74acdd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA207552
Marketing category
ANDA
Marketing start
2016-07-25
Marketing end
0000-00-00
Substance
FUROSEMIDE
Active strength
100 mg/10mL
Pharmacologic classes
Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70121-1076DDiscontinued by firm2026-10-05
excluded packagepackage70121-107670121-1076-5DDiscontinued by firm2026-10-05

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
A207552-001FUROSEMIDEFUROSEMIDE10MG/MLINJECTABLE / INJECTION2016-07-20

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 22:38:342026-08A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION2016-07-2084e616aacf4f…
2026-08-18 06:07:402026-07A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION2016-07-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION2016-07-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION2016-07-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION2016-07-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION2016-07-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION2016-07-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION2016-07-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION2016-07-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION2016-07-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION2016-07-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-203f01610625f2…
2019-09-15 20:21 UTC2019-09A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2016-07-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION2016-07-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION2016-07-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION2016-07-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION2016-07-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION2016-07-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207552-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION2016-07-20f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207552-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207552-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207552-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207552-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207552-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207552-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207552-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207552-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207552-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207552-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207552-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207552-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207552-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207552-001AP18072bd15b7f6…
2019-12-13 00:20 UTC2019-12A207552-001AP174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A207552-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A207552-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207552-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207552-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207552-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207552-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207552-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207552-001AP19b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207552-001AP1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
70121-1076-1Furosemide10 mL in 1 VIAL, GLASSINJECTION1014
70121-1076-5Furosemide25 in 1 CARTONINJECTION2514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1076-1ML - Milliliter70121-1076d1d042dd-0ee1-4655-88e2-37777a561e3b12017-10-13
70121-1076-5ML - Milliliter70121-10763c7e2bb6-0b7b-427c-be7c-570991d860c012017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1076FUROSEMIDE INJECTION [AMNEAL PHARMACEUTICALS LLC]14Legacy NDC, 2 package rows20250315_d5b9f12e-d1e9-42de-90f2-c9ba33a86457.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719286furosemide 100 MG in 10 ML InjectionPSNd5b9f12e-d1e9-42de-90f2-c9ba33a8645714
1719290furosemide 20 MG in 2 ML InjectionPSNd5b9f12e-d1e9-42de-90f2-c9ba33a8645714
1719291furosemide 40 MG in 4 ML InjectionPSNd5b9f12e-d1e9-42de-90f2-c9ba33a8645714
171928610 ML furosemide 10 MG/ML InjectionSCDd5b9f12e-d1e9-42de-90f2-c9ba33a8645714
17192902 ML furosemide 10 MG/ML InjectionSCDd5b9f12e-d1e9-42de-90f2-c9ba33a8645714
17192914 ML furosemide 10 MG/ML InjectionSCDd5b9f12e-d1e9-42de-90f2-c9ba33a8645714
1719286furosemide 100 MG per 10 ML InjectionSYd5b9f12e-d1e9-42de-90f2-c9ba33a8645714
1719290furosemide 20 MG per 2 ML InjectionSYd5b9f12e-d1e9-42de-90f2-c9ba33a8645714
1719291furosemide 40 MG per 4 ML InjectionSYd5b9f12e-d1e9-42de-90f2-c9ba33a8645714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1076-17012110760110 mL in 1 VIAL, GLASS10 mlHistorical
70121-1076-57012110760525 VIAL, GLASS in 1 CARTON (70121-1076-5) > 10 mL in 1 VIAL, GLASS (70121-1076-1) 2016-07-250000-00-00NoNoCurrent