FDA.reportPublic FDA data

Furosemide

Product NDC
68094-867
11-digit product format
680940867
Labeler code
68094
Product ID
68094-867_1fbbdc90-7827-439a-8502-6f7a41a7c936
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
SOLUTION
Route
ORAL
Labeler
Precision Dose Inc.
Application
ANDA070433
Marketing category
ANDA
Marketing start
2016-01-28
Substance
FUROSEMIDE
Active strength
40 mg/5mL
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
FUROSEMIDE40 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7LXU5N7ZO5
Rxcui197731

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
68094-867-59Furosemide5 mL in 1 CUP, UNIT-DOSESOLUTION56
68094-867-62Furosemide10 in 1 TRAYSOLUTION106
68094-867-62Furosemide3 in 1 CASESOLUTION36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-867-59ML - Milliliter68094-867bbe87e27-de8a-4da0-8a0d-071d87b1a01b12016-04-04
68094-867-62ML - Milliliter68094-867449dfbcd-7178-4a6b-9033-28d8157b7bc212016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-867FUROSEMIDE SOLUTION [PRECISION DOSE INC.]6Current NDC, Legacy NDC, 3 package rows20240707_3fd02fb5-98a0-4eda-a0ec-41faabe04706.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197731furosemide 40 MG in 5 mL Oral SolutionPSN3fd02fb5-98a0-4eda-a0ec-41faabe047066
197731furosemide 8 MG/ML Oral SolutionSCD3fd02fb5-98a0-4eda-a0ec-41faabe047066
197731furosemide 40 MG per 5 ML Oral SolutionSY3fd02fb5-98a0-4eda-a0ec-41faabe047066

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-867-59680940867595 mL in 1 CUP, UNIT-DOSE5 mlHistorical
68094-867-62680940867623 TRAY in 1 CASE (68094-867-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-867-59) 3 tray2016-01-280000-00-00NoNoCurrent