FDA.reportPublic FDA data

Gentamicin

Product NDC
55150-401
11-digit product format
551500401
Labeler code
55150
Product ID
55150-401_ec7eac4d-564f-4f16-b90a-a0c54d403056
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA215236
Marketing category
ANDA
Marketing start
2024-01-08
Substance
GENTAMICIN SULFATE
Active strength
10 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 SULFATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8X7386QRLV
Rxcui1870676

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
55150-401-01Gentamicin2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION22
55150-401-25Gentamicin25 in 1 CARTONINJECTION, SOLUTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-401-01ML - Milliliter55150-401614d970c-08b4-4fc8-aba9-125536b63ef112024-04-05
55150-401-25ML - Milliliter55150-401faf84610-6381-4d73-abdc-213b9d6971b112024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-401GENTAMICIN INJECTION, SOLUTION [EUGIA US LLC]1Current NDC, 2 package rows20240110_f8c608b3-50b8-4d5d-9e8a-e92c0d2e3cdc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870676gentamicin sulfate 20 MG in 2 ML InjectionPSNf8c608b3-50b8-4d5d-9e8a-e92c0d2e3cdc2
18706762 ML gentamicin 10 MG/ML InjectionSCDf8c608b3-50b8-4d5d-9e8a-e92c0d2e3cdc2
1870676gentamicin (as gentamicin sulfate) 20 MG per 2 ML InjectionSYf8c608b3-50b8-4d5d-9e8a-e92c0d2e3cdc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55150-401-01551500401012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
55150-401-255515004012525 VIAL, SINGLE-DOSE in 1 CARTON (55150-401-25) / 2 mL in 1 VIAL, SINGLE-DOSE (55150-401-01) 2024-01-08NoNoHistorical