FDA.reportPublic FDA data

Gentamicin

Product NDC
63323-173
11-digit product format
633230173
Labeler code
63323
Product ID
63323-173_9f48c9f7-08fd-4652-911c-c2c221a34ed3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GENTAMICIN
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA062366
Marketing category
ANDA
Marketing start
2004-11-29
Substance
GENTAMICIN SULFATE
Active strength
10 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gentamicin
Listing expiration
2026-12-31

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
63323-173-01Gentamicin2 mL in 1 VIALINJECTION, SOLUTION28
63323-173-02Gentamicin25 in 1 TRAYINJECTION, SOLUTION258
63323-173-41Gentamicin2 mL in 1 VIALINJECTION, SOLUTION24
63323-173-94Gentamicin25 in 1 TRAYINJECTION, SOLUTION254
63323-173-95Gentamicin25 in 1 TRAYINJECTION, SOLUTION253
63323-173-95Gentamicin2 mL in 1 VIALINJECTION, SOLUTION23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-173-01ML - Milliliter63323-173ced61a19-c526-4301-9865-ba40e8c2182012022-08-04
63323-173-02ML - Milliliter63323-1735fd11ec3-8c33-4c79-b4c7-bec645fb287312012-07-24
63323-173-41ML - Milliliter63323-173d5f59524-b9ee-4918-b264-40afffbbcc2e12023-01-09
63323-173-94ML - Milliliter63323-17353fc2922-96f5-4ce1-8684-be9e028a9a6e12013-12-02
63323-173-95ML - Milliliter63323-173f3a52ac6-ae2b-4af9-8def-100e9d3032b712014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-173GENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]8Current NDC, Legacy NDC, 2 package rows20231215_be5b414e-d598-4721-80ee-5836156ad210.zip
63323-173GENTAMICIN (GENTAMICIN) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC, 2 package rows20240106_8bdeef7f-ad8e-46e0-a872-e945eae51d68.zip
63323-173GENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 2 package rows20241017_63413469-c676-48a3-a945-7d2489b535ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870676gentamicin sulfate 20 MG in 2 ML InjectionPSNbe5b414e-d598-4721-80ee-5836156ad2108
18706762 ML gentamicin 10 MG/ML InjectionSCDbe5b414e-d598-4721-80ee-5836156ad2108
1870676gentamicin (as gentamicin sulfate) 20 MG per 2 ML InjectionSYbe5b414e-d598-4721-80ee-5836156ad2108
1870676gentamicin sulfate 20 MG in 2 ML InjectionPSN8bdeef7f-ad8e-46e0-a872-e945eae51d684
18706762 ML gentamicin 10 MG/ML InjectionSCD8bdeef7f-ad8e-46e0-a872-e945eae51d684
1870676gentamicin (as gentamicin sulfate) 20 MG per 2 ML InjectionSY8bdeef7f-ad8e-46e0-a872-e945eae51d684
1870676gentamicin sulfate 20 MG in 2 ML InjectionPSN63413469-c676-48a3-a945-7d2489b535ef3
18706762 ML gentamicin 10 MG/ML InjectionSCD63413469-c676-48a3-a945-7d2489b535ef3
1870676gentamicin (as gentamicin sulfate) 20 MG per 2 ML InjectionSY63413469-c676-48a3-a945-7d2489b535ef3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-173-01633230173012 mL in 1 VIAL2 mlHistorical
63323-173-026332301730225 VIAL in 1 TRAY (63323-173-02) / 2 mL in 1 VIAL (63323-173-01) 25 vial2004-11-290000-00-00NoNoCurrent
63323-173-41633230173412 mL in 1 VIAL2 mlHistorical
63323-173-946332301739425 VIAL in 1 TRAY (63323-173-94) / 2 mL in 1 VIAL (63323-173-41) 25 vial2004-11-290000-00-00NoNoCurrent
63323-173-956332301739525 VIAL in 1 TRAY (63323-173-95) / 2 mL in 1 VIAL25 vial2004-11-290000-00-00NoNoCurrent