FDA.reportPublic FDA data

Furosemide

Product NDC
63323-280
11-digit product format
633230280
Labeler code
63323
Product ID
63323-280_64b3fb5f-3516-4e39-b74e-e0e402ed9c4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FUROSEMIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, 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

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 Identifiers#

Field, Values table
FieldValues
Unii7LXU5N7ZO5
Rxcui1719286, 1719290, 1719291

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
63323-280-01Furosemide2 mL in 1 VIALINJECTION, SOLUTION26
63323-280-02Furosemide25 in 1 TRAYINJECTION, SOLUTION256
63323-280-03Furosemide4 mL in 1 VIALINJECTION, SOLUTION46
63323-280-04Furosemide25 in 1 TRAYINJECTION, SOLUTION256
63323-280-05Furosemide10 mL in 1 VIALINJECTION, SOLUTION106
63323-280-10Furosemide25 in 1 TRAYINJECTION, SOLUTION256
63323-280-16Furosemide25 in 1 TRAYINJECTION, SOLUTION255
63323-280-26Furosemide25 in 1 TRAYINJECTION, SOLUTION255
63323-280-36Furosemide25 in 1 TRAYINJECTION, SOLUTION255
63323-280-41Furosemide2 mL in 1 VIALINJECTION, SOLUTION25
63323-280-43Furosemide4 mL in 1 VIALINJECTION, SOLUTION45
63323-280-45Furosemide10 mL in 1 VIALINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-280-01ML - Milliliter63323-280a1e6792f-738f-4914-aa73-f6864a32401812018-06-11
63323-280-02ML - Milliliter63323-280797d18c8-1115-4d5d-a5d9-33c611087c1512013-02-13
63323-280-03ML - Milliliter63323-2809a3e90b3-ba96-4df2-b0d8-3a8f075cbdf912018-06-11
63323-280-04ML - Milliliter63323-2800c6d853c-c40e-4c9b-bdcc-27361be6d4e312013-02-13
63323-280-05ML - Milliliter63323-280e2eef356-ff5b-4075-a6a3-903c2c5ff8d512018-06-11
63323-280-10ML - Milliliter63323-280e926401f-a7f2-4138-a9d4-5be8b0765c6612013-02-13
63323-280-16ML - Milliliter63323-28072c795da-c15f-4f86-af32-84244c93d46c12016-03-04
63323-280-26ML - Milliliter63323-2805a9e2614-a600-43de-9b72-90d84a2b81a012016-03-04
63323-280-36ML - Milliliter63323-2804a5f5201-9a05-46d0-9293-ca4ea292550d12016-05-16
63323-280-41ML - Milliliter63323-280af1d11ae-1d23-472d-bab0-604ae6eb927912023-12-05
63323-280-43ML - Milliliter63323-28028e47ad8-8858-41cc-bfca-12fbe4598f3e12025-09-12
63323-280-45ML - Milliliter63323-2809f666b54-17c3-43f1-b292-59e1ca98894312024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FUROSEMIDEACTIVE INGREDIENT7LXU5N7ZO5FUROSEMIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
FUROSEMIDEACTIVE MOIETY7LXU5N7ZO5FUROSEMIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFUROSEMIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFUROSEMIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFUROSEMIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-280FUROSEMIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 6 package rows20241222_c794c95a-654e-48fe-9596-201fc122ff75.zip
63323-280FUROSEMIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 6 package rows20241222_3747bbcd-783d-4baa-bb5b-b6827bf390e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719290furosemide 20 MG in 2 ML InjectionPSN42478c55-9056-487a-89a9-d36904beea127
17192902 ML furosemide 10 MG/ML InjectionSCD42478c55-9056-487a-89a9-d36904beea127
1719290furosemide 20 MG per 2 ML InjectionSY42478c55-9056-487a-89a9-d36904beea127
1719286furosemide 100 MG in 10 ML InjectionPSNc794c95a-654e-48fe-9596-201fc122ff756
1719290furosemide 20 MG in 2 ML InjectionPSNc794c95a-654e-48fe-9596-201fc122ff756
1719291furosemide 40 MG in 4 ML InjectionPSNc794c95a-654e-48fe-9596-201fc122ff756
1719291furosemide 40 MG in 4 ML InjectionPSNc5db4434-0b47-038c-e053-2995a90ad7fe6
171928610 ML furosemide 10 MG/ML InjectionSCDc794c95a-654e-48fe-9596-201fc122ff756
17192902 ML furosemide 10 MG/ML InjectionSCDc794c95a-654e-48fe-9596-201fc122ff756
17192914 ML furosemide 10 MG/ML InjectionSCDc794c95a-654e-48fe-9596-201fc122ff756
17192914 ML furosemide 10 MG/ML InjectionSCDc5db4434-0b47-038c-e053-2995a90ad7fe6
1719286furosemide 100 MG per 10 ML InjectionSYc794c95a-654e-48fe-9596-201fc122ff756
1719290furosemide 20 MG per 2 ML InjectionSYc794c95a-654e-48fe-9596-201fc122ff756
1719291furosemide 40 MG per 4 ML InjectionSYc5db4434-0b47-038c-e053-2995a90ad7fe6
1719291furosemide 40 MG per 4 ML InjectionSYc794c95a-654e-48fe-9596-201fc122ff756
1719286furosemide 100 MG in 10 ML InjectionPSN3747bbcd-783d-4baa-bb5b-b6827bf390e35
1719290furosemide 20 MG in 2 ML InjectionPSN3747bbcd-783d-4baa-bb5b-b6827bf390e35
1719291furosemide 40 MG in 4 ML InjectionPSNd75ba8bd-9494-4306-8443-9c1a90992dd55
1719291furosemide 40 MG in 4 ML InjectionPSN3747bbcd-783d-4baa-bb5b-b6827bf390e35
171928610 ML furosemide 10 MG/ML InjectionSCD3747bbcd-783d-4baa-bb5b-b6827bf390e35
17192902 ML furosemide 10 MG/ML InjectionSCD3747bbcd-783d-4baa-bb5b-b6827bf390e35
17192914 ML furosemide 10 MG/ML InjectionSCDd75ba8bd-9494-4306-8443-9c1a90992dd55
17192914 ML furosemide 10 MG/ML InjectionSCD3747bbcd-783d-4baa-bb5b-b6827bf390e35
1719286furosemide 100 MG per 10 ML InjectionSY3747bbcd-783d-4baa-bb5b-b6827bf390e35
1719290furosemide 20 MG per 2 ML InjectionSY3747bbcd-783d-4baa-bb5b-b6827bf390e35
1719291furosemide 40 MG per 4 ML InjectionSYd75ba8bd-9494-4306-8443-9c1a90992dd55
1719291furosemide 40 MG per 4 ML InjectionSY3747bbcd-783d-4baa-bb5b-b6827bf390e35
1719290furosemide 20 MG in 2 ML InjectionPSNc5db2be1-088f-1110-e053-2a95a90acac83
17192902 ML furosemide 10 MG/ML InjectionSCDc5db2be1-088f-1110-e053-2a95a90acac83
1719290furosemide 20 MG per 2 ML InjectionSYc5db2be1-088f-1110-e053-2a95a90acac83
1719286furosemide 100 MG in 10 ML InjectionPSNc5d9b063-e3fe-ec2f-e053-2995a90ab3f21
171928610 ML furosemide 10 MG/ML InjectionSCDc5d9b063-e3fe-ec2f-e053-2995a90ab3f21
1719286furosemide 100 MG per 10 ML InjectionSYc5d9b063-e3fe-ec2f-e053-2995a90ab3f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-280-01633230280012 mL in 1 VIAL2 mlHistorical
63323-280-026332302800225 VIAL in 1 TRAY (63323-280-02) / 2 mL in 1 VIAL (63323-280-01) 25 vial2000-07-120000-00-00NoNoCurrent
63323-280-03633230280034 mL in 1 VIAL4 mlHistorical
63323-280-046332302800425 VIAL in 1 TRAY (63323-280-04) / 4 mL in 1 VIAL (63323-280-03) 25 vial2000-07-120000-00-00NoNoCurrent
63323-280-056332302800510 mL in 1 VIAL10 mlHistorical
63323-280-106332302801025 VIAL in 1 TRAY (63323-280-10) / 10 mL in 1 VIAL (63323-280-05) 25 vial2000-07-120000-00-00NoNoCurrent
63323-280-166332302801625 VIAL in 1 TRAY (63323-280-16) / 2 mL in 1 VIAL (63323-280-41) 25 vial2000-07-120000-00-00NoNoCurrent
63323-280-266332302802625 VIAL in 1 TRAY (63323-280-26) / 4 mL in 1 VIAL (63323-280-43) 25 vial2000-07-120000-00-00NoNoCurrent
63323-280-366332302803625 VIAL in 1 TRAY (63323-280-36) / 10 mL in 1 VIAL (63323-280-45) 25 vial2000-07-120000-00-00NoNoCurrent
63323-280-41633230280412 mL in 1 VIAL2 mlHistorical
63323-280-43633230280434 mL in 1 VIAL4 mlHistorical
63323-280-456332302804510 mL in 1 VIAL10 mlHistorical