FDA.reportPublic FDA data

gentamicin sulfate

Product NDC
61919-106
11-digit product format
619190106
Labeler code
61919
Product ID
61919-106_0e997972-7ec7-5a7a-e063-6294a90aceac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gentamicin sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
DIRECT RX
Application
ANDA062452
Marketing category
ANDA
Marketing start
2014-01-01
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
d3946667-8212-d1f2-67e1-5643a329bb56Product name220200403
4ce5dce5-e8a7-e4f6-0059-b527e4307477Product name220190501
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-106-05gentamicin sulfate5 mL in 1 CARTONSOLUTION/ DROPS58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-106-05ML - Milliliter61919-10653f88367-178f-469a-9b66-ed330f180efe12016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
gentamicin sulfateACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]1
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KGENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBGENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]1
polyvinyl alcoholINACTIVE INGREDIENT532B59J990GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XGENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IGENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]1
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]1
waterINACTIVE INGREDIENT059QF0KO0RGENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-106GENTAMICIN SULFATE SOLUTION/ DROPS GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]8Current NDC, Legacy NDC, 1 package rows20240111_51a411a0-2671-4c1c-bf25-e29b32efed0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSN51a411a0-2671-4c1c-bf25-e29b32efed0c8
310467gentamicin 3 MG/ML Ophthalmic SolutionSCD51a411a0-2671-4c1c-bf25-e29b32efed0c8
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSY51a411a0-2671-4c1c-bf25-e29b32efed0c8
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSY51a411a0-2671-4c1c-bf25-e29b32efed0c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-106-05619190106055 mL in 1 CARTON (61919-106-05) 5 ml2015-05-070000-00-00NoNoCurrent