FDA.reportPublic FDA data

Furosemide

Product NDC
25021-320
11-digit product format
250210320
Labeler code
25021
Product ID
25021-320_29372fb6-0fa1-4caf-a55f-451091c93390
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA214766
Marketing category
ANDA
Marketing start
2025-07-15
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
25021-320-02Furosemide2 mL in 1 VIALINJECTION, SOLUTION21
25021-320-02Furosemide25 in 1 CARTONINJECTION, SOLUTION251
25021-320-04Furosemide4 mL in 1 VIALINJECTION, SOLUTION41
25021-320-04Furosemide25 in 1 CARTONINJECTION, SOLUTION251
25021-320-10Furosemide25 in 1 CARTONINJECTION, SOLUTION251
25021-320-10Furosemide10 mL in 1 VIALINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-320-02ML - Milliliter25021-320eb28a29a-94f2-4fe6-9f00-ffe947474a7b12025-08-11
25021-320-04ML - Milliliter25021-3208d31eddf-9c7a-4763-8d71-834a307e89b212025-08-11
25021-320-10ML - Milliliter25021-3201404c492-593a-4195-b723-0e404a701ad112025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719286furosemide 100 MG in 10 ML InjectionPSNd76bd85a-8e57-477e-9607-c9435f1e26fb1
1719290furosemide 20 MG in 2 ML InjectionPSNd76bd85a-8e57-477e-9607-c9435f1e26fb1
1719291furosemide 40 MG in 4 ML InjectionPSNd76bd85a-8e57-477e-9607-c9435f1e26fb1
171928610 ML furosemide 10 MG/ML InjectionSCDd76bd85a-8e57-477e-9607-c9435f1e26fb1
17192902 ML furosemide 10 MG/ML InjectionSCDd76bd85a-8e57-477e-9607-c9435f1e26fb1
17192914 ML furosemide 10 MG/ML InjectionSCDd76bd85a-8e57-477e-9607-c9435f1e26fb1
1719286furosemide 100 MG per 10 ML InjectionSYd76bd85a-8e57-477e-9607-c9435f1e26fb1
1719290furosemide 20 MG per 2 ML InjectionSYd76bd85a-8e57-477e-9607-c9435f1e26fb1
1719291furosemide 40 MG per 4 ML InjectionSYd76bd85a-8e57-477e-9607-c9435f1e26fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-320-022502103200225 VIAL in 1 CARTON (25021-320-02) / 2 mL in 1 VIAL25 vial2025-07-15NoNoHistorical
25021-320-042502103200425 VIAL in 1 CARTON (25021-320-04) / 4 mL in 1 VIAL25 vial2025-07-15NoNoHistorical
25021-320-102502103201025 VIAL in 1 CARTON (25021-320-10) / 10 mL in 1 VIAL25 vial2025-07-15NoNoHistorical