FDA.reportPublic FDA data

Furosemide

Product NDC
83980-004
11-digit product format
839800004
Labeler code
83980
Product ID
83980-004_2ef79eb1-61e5-4697-9292-336ca5cf5116
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
TABLET
Route
ORAL
Labeler
Ipca Laboratories Limited
Application
ANDA078010
Marketing category
ANDA
Marketing start
2024-06-03
Substance
FUROSEMIDE
Active strength
80 mg/1
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
FUROSEMIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7LXU5N7ZO5
Rxcui197732, 310429, 313988

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
83980-004-01Furosemide100 in 1 BOTTLETABLET1003
83980-004-05Furosemide500 in 1 BOTTLETABLET5003
83980-004-10Furosemide1000 in 1 BOTTLETABLET10003
83980-004-97Furosemide10 in 1 BOTTLETABLET103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83980-004-01EA - Each83980-004980ecccd-caec-4f6d-8348-f75d82497a6312024-08-12
83980-004-05EA - Each83980-0047ac9ace8-710b-4b5c-b3f5-f6ba3944854b12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83980-004FUROSEMIDE TABLET [IPCA LABORATORIES LIMITED]3Current NDC, 4 package rows20250121_0acd293b-ecab-4879-a8e7-cd1b76148f2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310429furosemide 20 MG Oral TabletPSN0acd293b-ecab-4879-a8e7-cd1b76148f2a3
313988furosemide 40 MG Oral TabletPSN0acd293b-ecab-4879-a8e7-cd1b76148f2a3
197732furosemide 80 MG Oral TabletPSN0acd293b-ecab-4879-a8e7-cd1b76148f2a3
310429furosemide 20 MG Oral TabletSCD0acd293b-ecab-4879-a8e7-cd1b76148f2a3
313988furosemide 40 MG Oral TabletSCD0acd293b-ecab-4879-a8e7-cd1b76148f2a3
197732furosemide 80 MG Oral TabletSCD0acd293b-ecab-4879-a8e7-cd1b76148f2a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83980-004-0183980000401100 TABLET in 1 BOTTLE (83980-004-01) 100 tablet2024-06-03NoNoHistorical
83980-004-0583980000405500 TABLET in 1 BOTTLE (83980-004-05) 500 tablet2024-06-03NoNoHistorical
83980-004-10839800004101000 TABLET in 1 BOTTLE (83980-004-10) 1000 tablet2024-06-03NoNoHistorical
83980-004-978398000049710 TABLET in 1 BOTTLE (83980-004-97) 10 tablet2024-06-03NoNoHistorical