FDA.reportPublic FDA data

Gentamicin Sulfate

Product NDC
24208-580
11-digit product format
242080580
Labeler code
24208
Product ID
24208-580_1dd9fcc1-daec-fa67-e063-6394a90a0139
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
ANDA064048
Marketing category
ANDA
Marketing start
1994-05-11
Substance
GENTAMICIN SULFATE
Active strength
3 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 Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GENTAMICIN SULFATE3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8X7386QRLV
Rxcui310467

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3b7b3a7a-635f-32a3-0c6c-7ad028e3de91Product name220250107
43025f0d-698c-68da-cec9-ea4261a7ef7aProduct name220250107
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
d3946667-8212-d1f2-67e1-5643a329bb56Product name220200403
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
4ce5dce5-e8a7-e4f6-0059-b527e4307477Product name220190501
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-580-60Gentamicin Sulfate1 in 1 CARTONSOLUTION/ DROPS115
24208-580-60Gentamicin Sulfate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS515
24208-580-64Gentamicin Sulfate15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1515
24208-580-64Gentamicin Sulfate1 in 1 CARTONSOLUTION/ DROPS115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-580-60ML - Milliliter24208-580462515c7-1366-46c5-87db-5b20a94dd6c912012-07-24
24208-580-64ML - Milliliter24208-580d1064568-058d-41df-b518-a1284803ebfc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7GENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XGENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74GENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWGENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
WATERINACTIVE INGREDIENT059QF0KO0RGENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]3
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7GENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XGENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]3
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74GENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]3
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWGENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RGENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]3
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]2
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7GENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XGENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74GENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWGENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]2
WATERINACTIVE INGREDIENT059QF0KO0RGENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]2
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]1
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XGENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XGENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWGENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWGENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RGENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RGENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-580GENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]15Current NDC, Legacy NDC, 4 package rows20240723_41d01350-5c4b-42fc-be5f-986ceec02bd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSN41d01350-5c4b-42fc-be5f-986ceec02bd315
310467gentamicin 3 MG/ML Ophthalmic SolutionSCD41d01350-5c4b-42fc-be5f-986ceec02bd315
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSY41d01350-5c4b-42fc-be5f-986ceec02bd315
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSY41d01350-5c4b-42fc-be5f-986ceec02bd315
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSN76fabcd6-4da3-49e3-85a1-ca4fac55a2079
310467gentamicin 3 MG/ML Ophthalmic SolutionSCD76fabcd6-4da3-49e3-85a1-ca4fac55a2079
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSY76fabcd6-4da3-49e3-85a1-ca4fac55a2079
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSY76fabcd6-4da3-49e3-85a1-ca4fac55a2079
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSN3a6677a6-def5-443e-82bc-c185d41f03b74
310467gentamicin 3 MG/ML Ophthalmic SolutionSCD3a6677a6-def5-443e-82bc-c185d41f03b74
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSY3a6677a6-def5-443e-82bc-c185d41f03b74
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSY3a6677a6-def5-443e-82bc-c185d41f03b74
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSNe1a5bc32-f9a0-6b33-e053-2995a90ab9ac3
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSN5ac8ea7a-ee89-49f5-8d30-6dbb56503d943
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSNfcb5baef-4760-4bb3-88dd-e3c3e3bb1a5d3
310467gentamicin 3 MG/ML Ophthalmic SolutionSCD5ac8ea7a-ee89-49f5-8d30-6dbb56503d943
310467gentamicin 3 MG/ML Ophthalmic SolutionSCDe1a5bc32-f9a0-6b33-e053-2995a90ab9ac3
310467gentamicin 3 MG/ML Ophthalmic SolutionSCDfcb5baef-4760-4bb3-88dd-e3c3e3bb1a5d3
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSY5ac8ea7a-ee89-49f5-8d30-6dbb56503d943
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSYfcb5baef-4760-4bb3-88dd-e3c3e3bb1a5d3
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSYe1a5bc32-f9a0-6b33-e053-2995a90ab9ac3
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSY5ac8ea7a-ee89-49f5-8d30-6dbb56503d943
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSYe1a5bc32-f9a0-6b33-e053-2995a90ab9ac3
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSYfcb5baef-4760-4bb3-88dd-e3c3e3bb1a5d3
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSN0bef2a01-69d0-cf50-e063-6294a90a4c522
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSN1f908b73-d829-4c6f-e054-00144ff8d46c2
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSNc3a08907-778d-4229-9f72-20cc4f57b10c2
310467gentamicin 3 MG/ML Ophthalmic SolutionSCDc3a08907-778d-4229-9f72-20cc4f57b10c2
310467gentamicin 3 MG/ML Ophthalmic SolutionSCD1f908b73-d829-4c6f-e054-00144ff8d46c2
310467gentamicin 3 MG/ML Ophthalmic SolutionSCD0bef2a01-69d0-cf50-e063-6294a90a4c522
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSY1f908b73-d829-4c6f-e054-00144ff8d46c2
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSY0bef2a01-69d0-cf50-e063-6294a90a4c522
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSYc3a08907-778d-4229-9f72-20cc4f57b10c2
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSYc3a08907-778d-4229-9f72-20cc4f57b10c2
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSY0bef2a01-69d0-cf50-e063-6294a90a4c522
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSY1f908b73-d829-4c6f-e054-00144ff8d46c2
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSNb59e49e0-640b-43c3-ad07-711d1bb154e91
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSN6c8b45b0-f45a-4137-8228-b38e125dede51
310467gentamicin 3 MG/ML Ophthalmic SolutionSCDb59e49e0-640b-43c3-ad07-711d1bb154e91
310467gentamicin 3 MG/ML Ophthalmic SolutionSCD6c8b45b0-f45a-4137-8228-b38e125dede51
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSYb59e49e0-640b-43c3-ad07-711d1bb154e91
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSY6c8b45b0-f45a-4137-8228-b38e125dede51
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSYb59e49e0-640b-43c3-ad07-711d1bb154e91
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSY6c8b45b0-f45a-4137-8228-b38e125dede51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24208-580-60242080580601 BOTTLE, DROPPER in 1 CARTON (24208-580-60) / 5 mL in 1 BOTTLE, DROPPER1994-05-110000-00-00NoNoCurrent
24208-580-642420805806415 mL in 1 BOTTLE, DROPPER15 mlHistorical