FDA.reportPublic FDA data

Furosemide

Product NDC
70121-1076
11-digit product format
701211076
Labeler code
70121
Product ID
70121-1076_0243d363-b856-4a4a-a160-a691ca8c6621
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA207552
Marketing category
ANDA
Marketing start
2016-07-25
Substance
FUROSEMIDE
Active strength
100 mg/10mL
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
FUROSEMIDE100 mg/10mL

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
70121-1076-1Furosemide10 mL in 1 VIAL, GLASSINJECTION1014
70121-1076-5Furosemide25 in 1 CARTONINJECTION2514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1076-1ML - Milliliter70121-1076d1d042dd-0ee1-4655-88e2-37777a561e3b12017-10-13
70121-1076-5ML - Milliliter70121-10763c7e2bb6-0b7b-427c-be7c-570991d860c012017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1076FUROSEMIDE INJECTION [AMNEAL PHARMACEUTICALS LLC]14Current NDC, Legacy NDC, 2 package rows20250315_d5b9f12e-d1e9-42de-90f2-c9ba33a86457.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719286furosemide 100 MG in 10 ML InjectionPSNd5b9f12e-d1e9-42de-90f2-c9ba33a8645714
1719290furosemide 20 MG in 2 ML InjectionPSNd5b9f12e-d1e9-42de-90f2-c9ba33a8645714
1719291furosemide 40 MG in 4 ML InjectionPSNd5b9f12e-d1e9-42de-90f2-c9ba33a8645714
171928610 ML furosemide 10 MG/ML InjectionSCDd5b9f12e-d1e9-42de-90f2-c9ba33a8645714
17192902 ML furosemide 10 MG/ML InjectionSCDd5b9f12e-d1e9-42de-90f2-c9ba33a8645714
17192914 ML furosemide 10 MG/ML InjectionSCDd5b9f12e-d1e9-42de-90f2-c9ba33a8645714
1719286furosemide 100 MG per 10 ML InjectionSYd5b9f12e-d1e9-42de-90f2-c9ba33a8645714
1719290furosemide 20 MG per 2 ML InjectionSYd5b9f12e-d1e9-42de-90f2-c9ba33a8645714
1719291furosemide 40 MG per 4 ML InjectionSYd5b9f12e-d1e9-42de-90f2-c9ba33a8645714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1076-17012110760110 mL in 1 VIAL, GLASS10 mlHistorical
70121-1076-57012110760525 VIAL, GLASS in 1 CARTON (70121-1076-5) / 10 mL in 1 VIAL, GLASS (70121-1076-1) 2016-07-250000-00-00NoNoCurrent