FDA.reportPublic FDA data

Furosemide

Product NDC
0143-9157
11-digit product format
001439157
Labeler code
0143
Product ID
0143-9157_febcfbde-87d9-4c2f-819f-dfb4a04082f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA018267
Marketing category
NDA
Marketing start
2024-08-19
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, 2683305, 2683306

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
0143-9157-01Furosemide10 mL in 1 VIAL, SINGLE-DOSEINJECTION107
0143-9157-10Furosemide10 in 1 CARTONINJECTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9157-01ML - Milliliter0143-9157c93f968a-f28f-492d-83b9-9069766f3ece12024-09-09
0143-9157-10ML - Milliliter0143-9157f652c632-768d-47ee-87a0-cc27118e013b12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9157FUROSEMIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]7Current NDC, 2 package rows20250312_ddfc41a9-37d4-49c1-bbf3-969a98cd649c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719286furosemide 100 MG in 10 ML InjectionPSNddfc41a9-37d4-49c1-bbf3-969a98cd649c7
2683306furosemide 1000 MG in 100 ML InjectionPSNddfc41a9-37d4-49c1-bbf3-969a98cd649c7
1719290furosemide 20 MG in 2 ML InjectionPSNddfc41a9-37d4-49c1-bbf3-969a98cd649c7
1719291furosemide 40 MG in 4 ML InjectionPSNddfc41a9-37d4-49c1-bbf3-969a98cd649c7
2683305furosemide 500 MG in 50 ML InjectionPSNddfc41a9-37d4-49c1-bbf3-969a98cd649c7
171928610 ML furosemide 10 MG/ML InjectionSCDddfc41a9-37d4-49c1-bbf3-969a98cd649c7
2683306100 ML furosemide 10 MG/ML InjectionSCDddfc41a9-37d4-49c1-bbf3-969a98cd649c7
17192902 ML furosemide 10 MG/ML InjectionSCDddfc41a9-37d4-49c1-bbf3-969a98cd649c7
17192914 ML furosemide 10 MG/ML InjectionSCDddfc41a9-37d4-49c1-bbf3-969a98cd649c7
268330550 ML furosemide 10 MG/ML InjectionSCDddfc41a9-37d4-49c1-bbf3-969a98cd649c7
1719286furosemide 100 MG per 10 ML InjectionSYddfc41a9-37d4-49c1-bbf3-969a98cd649c7
2683306furosemide 1000 MG per 100 ML InjectionSYddfc41a9-37d4-49c1-bbf3-969a98cd649c7
1719290furosemide 20 MG per 2 ML InjectionSYddfc41a9-37d4-49c1-bbf3-969a98cd649c7
1719291furosemide 40 MG per 4 ML InjectionSYddfc41a9-37d4-49c1-bbf3-969a98cd649c7
2683305furosemide 500 MG per 50 ML InjectionSYddfc41a9-37d4-49c1-bbf3-969a98cd649c7
1719286furosemide 100 MG in 10 ML InjectionPSN4227fab8-a64a-1c9e-e063-6294a90a06821
171928610 ML furosemide 10 MG/ML InjectionSCD4227fab8-a64a-1c9e-e063-6294a90a06821
1719286furosemide 100 MG per 10 ML InjectionSY4227fab8-a64a-1c9e-e063-6294a90a06821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9157-010014391570110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
0143-9157-100014391571010 VIAL, SINGLE-DOSE in 1 CARTON (0143-9157-10) / 10 mL in 1 VIAL, SINGLE-DOSE (0143-9157-01) 2024-08-19NoNoHistorical