FDA.reportPublic FDA data

Furosemide

Product NDC
71288-203
11-digit product format
712880203
Labeler code
71288
Product ID
71288-203_53a09c30-7295-4337-89a4-93d3748d6ea3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA212803
Marketing category
ANDA
Marketing start
2022-01-27
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
71288-203-02Furosemide2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION26
71288-203-03Furosemide25 in 1 CARTONINJECTION, SOLUTION256
71288-203-04Furosemide4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION46
71288-203-05Furosemide25 in 1 CARTONINJECTION, SOLUTION256
71288-203-10Furosemide10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION106
71288-203-11Furosemide25 in 1 CARTONINJECTION, SOLUTION256
71288-203-91Furosemide2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION21
71288-203-92Furosemide25 in 1 CARTONINJECTION, SOLUTION251
71288-203-93Furosemide10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION101
71288-203-94Furosemide25 in 1 CARTONINJECTION, SOLUTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-203-02ML - Milliliter71288-203992e6bd5-7ea3-496f-bbc5-8312f3de74b712022-08-04
71288-203-03ML - Milliliter71288-203ff4e0f06-db62-4093-92d4-1ee676a649c912022-08-04
71288-203-04ML - Milliliter71288-203b9ec57c8-242d-4c5c-82d3-f6c15def0a5812022-08-04
71288-203-05ML - Milliliter71288-20305be8fd5-b6d0-4700-8f11-8982fd98280412022-08-04
71288-203-10ML - Milliliter71288-2032f9c2eb9-138d-4141-9928-cee6affcd10612022-10-06
71288-203-11ML - Milliliter71288-203fdcb2b9a-650d-4d59-8a32-043c303d236712022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-203FUROSEMIDE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 6 package rows20250426_a2e3c748-28ce-4c50-a182-721912919840.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719286furosemide 100 MG in 10 ML InjectionPSNa2e3c748-28ce-4c50-a182-7219129198406
1719290furosemide 20 MG in 2 ML InjectionPSNa2e3c748-28ce-4c50-a182-7219129198406
1719291furosemide 40 MG in 4 ML InjectionPSNa2e3c748-28ce-4c50-a182-7219129198406
171928610 ML furosemide 10 MG/ML InjectionSCDa2e3c748-28ce-4c50-a182-7219129198406
17192902 ML furosemide 10 MG/ML InjectionSCDa2e3c748-28ce-4c50-a182-7219129198406
17192914 ML furosemide 10 MG/ML InjectionSCDa2e3c748-28ce-4c50-a182-7219129198406
1719286furosemide 100 MG per 10 ML InjectionSYa2e3c748-28ce-4c50-a182-7219129198406
1719290furosemide 20 MG per 2 ML InjectionSYa2e3c748-28ce-4c50-a182-7219129198406
1719291furosemide 40 MG per 4 ML InjectionSYa2e3c748-28ce-4c50-a182-7219129198406
1719286furosemide 100 MG in 10 ML InjectionPSN3aadaca7-3661-4bfe-87f8-6368e4ab65361
1719290furosemide 20 MG in 2 ML InjectionPSN3aadaca7-3661-4bfe-87f8-6368e4ab65361
1719291furosemide 40 MG in 4 ML InjectionPSN3aadaca7-3661-4bfe-87f8-6368e4ab65361
171928610 ML furosemide 10 MG/ML InjectionSCD3aadaca7-3661-4bfe-87f8-6368e4ab65361
17192902 ML furosemide 10 MG/ML InjectionSCD3aadaca7-3661-4bfe-87f8-6368e4ab65361
17192914 ML furosemide 10 MG/ML InjectionSCD3aadaca7-3661-4bfe-87f8-6368e4ab65361
1719286furosemide 100 MG per 10 ML InjectionSY3aadaca7-3661-4bfe-87f8-6368e4ab65361
1719290furosemide 20 MG per 2 ML InjectionSY3aadaca7-3661-4bfe-87f8-6368e4ab65361
1719291furosemide 40 MG per 4 ML InjectionSY3aadaca7-3661-4bfe-87f8-6368e4ab65361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-203-02712880203022 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
71288-203-037128802030325 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-03) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-203-02) 2022-01-270000-00-00NoNoCurrent
71288-203-04712880203044 mL in 1 VIAL, SINGLE-DOSE4 mlHistorical
71288-203-057128802030525 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-05) / 4 mL in 1 VIAL, SINGLE-DOSE (71288-203-04) 2022-01-270000-00-00NoNoCurrent
71288-203-107128802031010 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
71288-203-117128802031125 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-203-10) 2022-01-270000-00-00NoNoCurrent
71288-203-91712880203912 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
71288-203-927128802039225 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-92) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-203-91) 2022-01-27NoNoCurrent
71288-203-937128802039310 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
71288-203-947128802039425 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-94) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-203-93) 2022-01-27NoNoCurrent