FDA.reportPublic FDA data

Furosemide

Product NDC
68788-8799
11-digit product format
687888799
Labeler code
68788
Product ID
68788-8799_1494a93a-f1ee-46e2-a111-991f84c8cb3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA216629
Marketing category
ANDA
Marketing start
2025-01-01
Substance
FUROSEMIDE
Active strength
40 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
FUROSEMIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7LXU5N7ZO5
Rxcui313988

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
68788-8799-1Furosemide100 in 1 BOTTLETABLET1002
68788-8799-3Furosemide30 in 1 BOTTLETABLET302
68788-8799-6Furosemide60 in 1 BOTTLETABLET602
68788-8799-9Furosemide90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8799-1EA - Each68788-8799a1e4f7d6-870e-4112-a2e0-216927b4d36112025-02-10
68788-8799-3EA - Each68788-87997b5317d0-370c-42da-bdc9-22c1b0ba557b12025-02-10
68788-8799-6EA - Each68788-8799523941bd-729d-4da2-9a38-d16229bfb27412025-02-10
68788-8799-9EA - Each68788-8799824fe5b0-6346-410d-beba-c7272c112c0712025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8799FUROSEMIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20250101_adda78ee-0cf5-4613-a748-5d6571afe354.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313988furosemide 40 MG Oral TabletPSNadda78ee-0cf5-4613-a748-5d6571afe3542
313988furosemide 40 MG Oral TabletSCDadda78ee-0cf5-4613-a748-5d6571afe3542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8799-168788879901100 TABLET in 1 BOTTLE (68788-8799-1) 100 tablet2025-01-01NoNoHistorical
68788-8799-36878887990330 TABLET in 1 BOTTLE (68788-8799-3) 30 tablet2025-01-01NoNoHistorical
68788-8799-66878887990660 TABLET in 1 BOTTLE (68788-8799-6) 60 tablet2025-01-01NoNoHistorical
68788-8799-96878887990990 TABLET in 1 BOTTLE (68788-8799-9) 90 tablet2025-01-01NoNoHistorical