FDA.reportPublic FDA data

Furosemide

Product NDC
0054-4297
11-digit product format
000544297
Labeler code
0054
Product ID
0054-4297_bc62ddda-7639-4090-99f0-7dd4d13518f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA018823
Marketing category
NDA
Marketing start
1983-11-10
Substance
FUROSEMIDE
Active strength
20 mg/1
Pharmacologic classes
Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Furosemide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FUROSEMIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7LXU5N7ZO5
Rxcui197730, 197731, 197732, 310429, 313988

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
0054-4297-252022-08-05C16284748780-1e4f33bdf-a7a2-d8a0-e053-dadaa90a6e4eFurosemide Tablets, USP and Furosemide Oral Solution, USP Rx only
0054-4297-312022-08-05C16284748780-1e4f33bdf-a7a2-d8a0-e053-dadaa90a6e4eFurosemide Tablets, USP and Furosemide Oral Solution, USP Rx only
0054-4297-252022-07-29C16284748780-1e4f33bdf-a7a2-d8a0-e053-dadaa90a6e4eFurosemide Tablets, USP and Furosemide Oral Solution, USP Rx only
0054-4297-312022-07-29C16284748780-1e4f33bdf-a7a2-d8a0-e053-dadaa90a6e4eFurosemide Tablets, USP and Furosemide Oral Solution, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-4297-25Furosemide100 in 1 BOTTLE, PLASTICTABLET10018
0054-4297-31Furosemide1000 in 1 BOTTLE, PLASTICTABLET100018
0054-4297-25Furosemide100 in 1 BOTTLE, PLASTICTABLET1001
0054-4297-31Furosemide1000 in 1 BOTTLE, PLASTICTABLET10001
0054-8297-25Furosemide10 in 1 BOXTABLET101
0054-8297-25Furosemide100 in 1 BLISTER PACKTABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-4297FUROSEMIDE TABLET FUROSEMIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]16Current NDC, Legacy NDC, 2 package rows20250511_9e493331-dddd-496e-abf8-61747fb67aba.zip
0054-4297FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 4 package rows20070509_EA623E21-E9FD-4EF1-843B-82CBC05AF5BF.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197730furosemide 10 MG in 1 mL Oral SolutionPSN9e493331-dddd-496e-abf8-61747fb67aba18
310429furosemide 20 MG Oral TabletPSN9e493331-dddd-496e-abf8-61747fb67aba18
197731furosemide 40 MG in 5 mL Oral SolutionPSN9e493331-dddd-496e-abf8-61747fb67aba18
313988furosemide 40 MG Oral TabletPSN9e493331-dddd-496e-abf8-61747fb67aba18
197732furosemide 80 MG Oral TabletPSN9e493331-dddd-496e-abf8-61747fb67aba18
197730furosemide 10 MG/ML Oral SolutionSCD9e493331-dddd-496e-abf8-61747fb67aba18
310429furosemide 20 MG Oral TabletSCD9e493331-dddd-496e-abf8-61747fb67aba18
313988furosemide 40 MG Oral TabletSCD9e493331-dddd-496e-abf8-61747fb67aba18
197731furosemide 8 MG/ML Oral SolutionSCD9e493331-dddd-496e-abf8-61747fb67aba18
197732furosemide 80 MG Oral TabletSCD9e493331-dddd-496e-abf8-61747fb67aba18
197730furosemide 1 % Oral SolutionSY9e493331-dddd-496e-abf8-61747fb67aba18
197730furosemide 10 MG per 1 ML Oral SolutionSY9e493331-dddd-496e-abf8-61747fb67aba18
197730furosemide 40 MG per 4 ML Oral SolutionSY9e493331-dddd-496e-abf8-61747fb67aba18
197731furosemide 40 MG per 5 ML Oral SolutionSY9e493331-dddd-496e-abf8-61747fb67aba18
310429furosemide 20 MG Oral TabletPSNa2e46e16-4adf-4599-b69d-a6f6f891ba7517
310429furosemide 20 MG Oral TabletSCDa2e46e16-4adf-4599-b69d-a6f6f891ba7517
310429furosemide 20 MG Oral TabletPSN6fbf7f3d-7566-44d5-9507-c4460238fc914
310429furosemide 20 MG Oral TabletPSNf3173c0d-2b62-7c7b-e053-2995a90ada054
313988furosemide 40 MG Oral TabletPSN6fbf7f3d-7566-44d5-9507-c4460238fc914
310429furosemide 20 MG Oral TabletSCDf3173c0d-2b62-7c7b-e053-2995a90ada054
310429furosemide 20 MG Oral TabletSCD6fbf7f3d-7566-44d5-9507-c4460238fc914
313988furosemide 40 MG Oral TabletSCD6fbf7f3d-7566-44d5-9507-c4460238fc914
197730furosemide 10 MG in 1 mL Oral SolutionPSNea623e21-e9fd-4ef1-843b-82cbc05af5bf1
310429furosemide 20 MG Oral TabletPSNea623e21-e9fd-4ef1-843b-82cbc05af5bf1
197731furosemide 40 MG in 5 mL Oral SolutionPSNea623e21-e9fd-4ef1-843b-82cbc05af5bf1
313988furosemide 40 MG Oral TabletPSNea623e21-e9fd-4ef1-843b-82cbc05af5bf1
197732furosemide 80 MG Oral TabletPSNea623e21-e9fd-4ef1-843b-82cbc05af5bf1
197730furosemide 10 MG/ML Oral SolutionSCDea623e21-e9fd-4ef1-843b-82cbc05af5bf1
310429furosemide 20 MG Oral TabletSCDea623e21-e9fd-4ef1-843b-82cbc05af5bf1
313988furosemide 40 MG Oral TabletSCDea623e21-e9fd-4ef1-843b-82cbc05af5bf1
197731furosemide 8 MG/ML Oral SolutionSCDea623e21-e9fd-4ef1-843b-82cbc05af5bf1
197732furosemide 80 MG Oral TabletSCDea623e21-e9fd-4ef1-843b-82cbc05af5bf1
197730furosemide 1 % Oral SolutionSYea623e21-e9fd-4ef1-843b-82cbc05af5bf1
197730furosemide 10 MG per 1 ML Oral SolutionSYea623e21-e9fd-4ef1-843b-82cbc05af5bf1
197730furosemide 40 MG per 4 ML Oral SolutionSYea623e21-e9fd-4ef1-843b-82cbc05af5bf1
197731furosemide 40 MG per 5 ML Oral SolutionSYea623e21-e9fd-4ef1-843b-82cbc05af5bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-4297-2500054429725100 TABLET in 1 BOTTLE, PLASTIC (0054-4297-25) 100 tablet1983-11-100000-00-00NoNoCurrent
0054-4297-31000544297311000 TABLET in 1 BOTTLE, PLASTIC (0054-4297-31) 1000 tablet1983-11-100000-00-00NoNoCurrent
0054-8297-250005482972510 in 1 BOXHistorical