FDA.reportPublic FDA data

Gentamicin

Product NDC
55150-402
11-digit product format
551500402
Labeler code
55150
Product ID
55150-402_c72dacd5-33b4-456e-ad96-0e8635a73854
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA215237
Marketing category
ANDA
Marketing start
2024-01-08
Substance
GENTAMICIN SULFATE
Active strength
40 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gentamicin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GENTAMICIN SULFATE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8X7386QRLV
Rxcui313996

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3b7b3a7a-635f-32a3-0c6c-7ad028e3de91Product name220250107
43025f0d-698c-68da-cec9-ea4261a7ef7aProduct name220250107
d3946667-8212-d1f2-67e1-5643a329bb56Product name220200403
4ce5dce5-e8a7-e4f6-0059-b527e4307477Product name220190501
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-402-01Gentamicin2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION22
55150-402-25Gentamicin25 in 1 CARTONINJECTION, SOLUTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-402-01ML - Milliliter55150-40204becccd-cf0e-4232-ae25-efa7edc2934d12024-04-05
55150-402-25ML - Milliliter55150-402789bcc4e-427a-4834-a97d-fb0e90b16ad412024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-402GENTAMICIN INJECTION, SOLUTION [EUGIA US LLC]1Current NDC, 2 package rows20240110_60ca1487-392d-4721-aa45-3de38722896c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313996gentamicin sulfate 40 MG/ML Injectable SolutionPSN60ca1487-392d-4721-aa45-3de38722896c2
313996gentamicin 40 MG/ML Injectable SolutionSCD60ca1487-392d-4721-aa45-3de38722896c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55150-402-01551500402012 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
55150-402-255515004022525 VIAL, MULTI-DOSE in 1 CARTON (55150-402-25) / 2 mL in 1 VIAL, MULTI-DOSE (55150-402-01) 2024-01-08NoNoCurrent