FDA.reportPublic FDA data

Gentamicin

Product NDC
63323-010
11-digit product format
633230010
Labeler code
63323
Product ID
63323-010_092ee018-3026-4c10-a751-2043e980b09f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GENTAMICIN SULFATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA062366
Marketing category
ANDA
Marketing start
2000-08-10
Substance
GENTAMICIN SULFATE
Active strength
40 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 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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
63323-010-01Gentamicin2 mL in 1 VIALINJECTION, SOLUTION27
63323-010-02Gentamicin25 in 1 TRAYINJECTION, SOLUTION257
63323-010-03Gentamicin20 mL in 1 VIALINJECTION, SOLUTION207
63323-010-20Gentamicin25 in 1 TRAYINJECTION, SOLUTION257
63323-010-41Gentamicin2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION24
63323-010-42Gentamicin20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION204
63323-010-94Gentamicin25 in 1 TRAYINJECTION, SOLUTION254
63323-010-95Gentamicin25 in 1 TRAYINJECTION, SOLUTION254
63323-010-96Gentamicin25 in 1 TRAYINJECTION, SOLUTION253
63323-010-96Gentamicin20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-010-01ML - Milliliter63323-0108f7fbb9f-e4ee-4c24-9cbf-cf5bb8b1d5fa12021-11-09
63323-010-02ML - Milliliter63323-01092538238-da65-4ed7-8897-630760fe2e7c12013-02-13
63323-010-03ML - Milliliter63323-01019616f55-e7a5-4305-8fdd-aa5fe3efe73c12021-10-08
63323-010-20ML - Milliliter63323-010c14a0d40-777c-4160-864c-67db4bc4ef4312013-02-13
63323-010-41ML - Milliliter63323-0104a00898e-ee4d-42cf-ac5d-a838db4deae912021-11-09
63323-010-42ML - Milliliter63323-01012f4a20a-beb2-4941-b432-2e768988c15512021-11-09
63323-010-94ML - Milliliter63323-01068aa80b2-bd39-4e78-ba34-50985d84379c12013-12-02
63323-010-95ML - Milliliter63323-0102f852c4c-085f-4c84-ab61-7553ed9f830c12013-12-02
63323-010-96ML - Milliliter63323-010fc20bbf7-9d1b-4004-a475-7c44486c15dd12014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-010GENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 4 package rows20231215_a73a5453-c091-43fd-aae2-d992152363b1.zip
63323-010GENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC, 4 package rows20231219_0cce2238-28d3-4280-b520-ffc3067a2ffa.zip
63323-010GENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 2 package rows20241017_84f5c763-1cd3-4d85-9afb-934db8666fbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313996gentamicin sulfate 40 MG/ML Injectable SolutionPSNa73a5453-c091-43fd-aae2-d992152363b17
313996gentamicin 40 MG/ML Injectable SolutionSCDa73a5453-c091-43fd-aae2-d992152363b17
313996gentamicin sulfate 40 MG/ML Injectable SolutionPSN84f6eb1c-a287-489a-8c3e-aa5954cf19926
313996gentamicin 40 MG/ML Injectable SolutionSCD84f6eb1c-a287-489a-8c3e-aa5954cf19926
313996gentamicin sulfate 40 MG/ML Injectable SolutionPSN0cce2238-28d3-4280-b520-ffc3067a2ffa4
313996gentamicin 40 MG/ML Injectable SolutionSCD0cce2238-28d3-4280-b520-ffc3067a2ffa4
313996gentamicin sulfate 40 MG/ML Injectable SolutionPSN84f5c763-1cd3-4d85-9afb-934db8666fbf3
313996gentamicin sulfate 40 MG/ML Injectable SolutionPSNc1ff0cdc-ac5d-30ca-e053-2a95a90a50663
313996gentamicin 40 MG/ML Injectable SolutionSCD84f5c763-1cd3-4d85-9afb-934db8666fbf3
313996gentamicin 40 MG/ML Injectable SolutionSCDc1ff0cdc-ac5d-30ca-e053-2a95a90a50663
313996gentamicin sulfate 40 MG/ML Injectable SolutionPSN09cf88af-59da-f147-e063-6294a90aac991
313996gentamicin 40 MG/ML Injectable SolutionSCD09cf88af-59da-f147-e063-6294a90aac991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-010-01633230010012 mL in 1 VIAL2 mlHistorical
63323-010-026332300100225 VIAL in 1 TRAY (63323-010-02) / 2 mL in 1 VIAL (63323-010-01) 25 vial2000-08-100000-00-00NoNoCurrent
63323-010-036332300100320 mL in 1 VIAL20 mlHistorical
63323-010-206332300102025 VIAL in 1 TRAY (63323-010-20) / 20 mL in 1 VIAL (63323-010-03) 25 vial2000-08-100000-00-00NoNoCurrent
63323-010-41633230010412 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
63323-010-426332300104220 mL in 1 VIAL, MULTI-DOSE20 mlHistorical
63323-010-946332300109425 VIAL, MULTI-DOSE in 1 TRAY (63323-010-94) / 2 mL in 1 VIAL, MULTI-DOSE (63323-010-41) 2000-08-100000-00-00NoNoCurrent
63323-010-956332300109525 VIAL, MULTI-DOSE in 1 TRAY (63323-010-95) / 20 mL in 1 VIAL, MULTI-DOSE (63323-010-42) 2000-08-100000-00-00NoNoCurrent
63323-010-966332300109625 VIAL, MULTI-DOSE in 1 TRAY (63323-010-96) / 20 mL in 1 VIAL, MULTI-DOSE2000-08-100000-00-00NoNoCurrent