FDA.reportPublic FDA data

Gentamicin Sulfate

Product NDC
61314-633
11-digit product format
613140633
Labeler code
61314
Product ID
61314-633_a628d79b-79de-49ec-b116-c605ba0fb991
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
ANDA062196
Marketing category
ANDA
Marketing start
1996-04-05
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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
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
61314-633-05Gentamicin Sulfate5 mL in 1 BOTTLE, DROPPERSOLUTION59
61314-633-05Gentamicin Sulfate1 in 1 CARTONSOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-633-05ML - Milliliter61314-6337f3d9c77-40cf-4ab8-9b40-b966eba6104712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE SOLUTION [SANDOZ INC]4
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE SOLUTION [SANDOZ INC]4
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7GENTAMICIN SULFATE SOLUTION [SANDOZ INC]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGENTAMICIN SULFATE SOLUTION [SANDOZ INC]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XGENTAMICIN SULFATE SOLUTION [SANDOZ INC]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN SULFATE SOLUTION [SANDOZ INC]4
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37GENTAMICIN SULFATE SOLUTION [SANDOZ INC]4
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56GENTAMICIN SULFATE SOLUTION [SANDOZ INC]4
WATERINACTIVE INGREDIENT059QF0KO0RGENTAMICIN SULFATE SOLUTION [SANDOZ INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-633GENTAMICIN SULFATE SOLUTION [SANDOZ INC]9Current NDC, Legacy NDC, 2 package rows20240524_a213fb9c-08ea-4f30-a6c9-93c7a9ba5280.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSNa213fb9c-08ea-4f30-a6c9-93c7a9ba52809
310467gentamicin 3 MG/ML Ophthalmic SolutionSCDa213fb9c-08ea-4f30-a6c9-93c7a9ba52809
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSYa213fb9c-08ea-4f30-a6c9-93c7a9ba52809
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSYa213fb9c-08ea-4f30-a6c9-93c7a9ba52809
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSN82595309-304e-a221-e053-2991aa0ac0a95
310467gentamicin 3 MG/ML Ophthalmic SolutionSCD82595309-304e-a221-e053-2991aa0ac0a95
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSY82595309-304e-a221-e053-2991aa0ac0a95
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSY82595309-304e-a221-e053-2991aa0ac0a95
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSN5193ed8d-44c9-46fe-924d-93aaea922cfd3
310467gentamicin 3 MG/ML Ophthalmic SolutionSCD5193ed8d-44c9-46fe-924d-93aaea922cfd3
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSY5193ed8d-44c9-46fe-924d-93aaea922cfd3
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSY5193ed8d-44c9-46fe-924d-93aaea922cfd3
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSNa54e5c95-609d-4d66-9573-5d1ac78fa58f1
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSN1c0612d1-e88d-e7da-e063-6294a90ad4f01
310467gentamicin 3 MG/ML Ophthalmic SolutionSCD1c0612d1-e88d-e7da-e063-6294a90ad4f01
310467gentamicin 3 MG/ML Ophthalmic SolutionSCDa54e5c95-609d-4d66-9573-5d1ac78fa58f1
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSY1c0612d1-e88d-e7da-e063-6294a90ad4f01
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSYa54e5c95-609d-4d66-9573-5d1ac78fa58f1
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSYa54e5c95-609d-4d66-9573-5d1ac78fa58f1
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSY1c0612d1-e88d-e7da-e063-6294a90ad4f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61314-633-05613140633051 BOTTLE, DROPPER in 1 CARTON (61314-633-05) / 5 mL in 1 BOTTLE, DROPPER1996-04-050000-00-00NoNoCurrent