FDA.reportPublic FDA data

Furosemide

Product NDC
83634-302
11-digit product format
836340302
Labeler code
83634
Product ID
83634-302_1b3f2803-b618-4447-b5ac-cd2bdc7de3e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
furosemide
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Avenacy Inc.
Application
ANDA203428
Marketing category
ANDA
Marketing start
2024-03-15
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
83634-302-02Furosemide25 in 1 CARTONINJECTION, SOLUTION254
83634-302-04Furosemide25 in 1 CARTONINJECTION, SOLUTION254
83634-302-10Furosemide25 in 1 CARTONINJECTION, SOLUTION254
83634-302-41Furosemide10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION104
83634-302-42Furosemide2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION24
83634-302-43Furosemide4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-302FUROSEMIDE INJECTION, SOLUTION [AVENACY INC.]4Current NDC, 6 package rows20250416_7d0db0f7-bf4f-4b0b-9359-2a838626e04b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719286furosemide 100 MG in 10 ML InjectionPSN7d0db0f7-bf4f-4b0b-9359-2a838626e04b4
1719290furosemide 20 MG in 2 ML InjectionPSN7d0db0f7-bf4f-4b0b-9359-2a838626e04b4
1719291furosemide 40 MG in 4 ML InjectionPSN7d0db0f7-bf4f-4b0b-9359-2a838626e04b4
171928610 ML furosemide 10 MG/ML InjectionSCD7d0db0f7-bf4f-4b0b-9359-2a838626e04b4
17192902 ML furosemide 10 MG/ML InjectionSCD7d0db0f7-bf4f-4b0b-9359-2a838626e04b4
17192914 ML furosemide 10 MG/ML InjectionSCD7d0db0f7-bf4f-4b0b-9359-2a838626e04b4
1719286furosemide 100 MG per 10 ML InjectionSY7d0db0f7-bf4f-4b0b-9359-2a838626e04b4
1719290furosemide 20 MG per 2 ML InjectionSY7d0db0f7-bf4f-4b0b-9359-2a838626e04b4
1719291furosemide 40 MG per 4 ML InjectionSY7d0db0f7-bf4f-4b0b-9359-2a838626e04b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83634-302-028363403020225 VIAL, SINGLE-DOSE in 1 CARTON (83634-302-02) / 2 mL in 1 VIAL, SINGLE-DOSE (83634-302-42) 2024-03-15NoNoCurrent
83634-302-048363403020425 VIAL, SINGLE-DOSE in 1 CARTON (83634-302-04) / 4 mL in 1 VIAL, SINGLE-DOSE (83634-302-43) 2024-03-15NoNoCurrent
83634-302-108363403021025 VIAL, SINGLE-DOSE in 1 CARTON (83634-302-10) / 10 mL in 1 VIAL, SINGLE-DOSE (83634-302-41) 2024-03-15NoNoCurrent
83634-302-418363403024110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
83634-302-42836340302422 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
83634-302-43836340302434 mL in 1 VIAL, SINGLE-DOSE4 mlHistorical