FDA.reportPublic FDA data

Gentamicin Sulfate

Product NDC
50436-6752
11-digit product format
504366752
Labeler code
50436
Product ID
50436-6752_846d26c3-9e4f-466a-870c-03438e73de47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Unit Dose Services
Application
ANDA064048
Marketing category
ANDA
Marketing start
1994-05-11
Marketing end
0000-00-00
Substance
GENTAMICIN SULFATE
Active strength
3 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-6752-12020-01-31C16284748780-19d75b9d1-2a99-f424-e053-dadaa90a57ceGentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-6752-1Gentamicin Sulfate15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-6752-1ML - Milliliter50436-67527e4f7cd8-bcd9-4150-bee9-9965f020e5ac12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-6752GENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20140401_c3a08907-778d-4229-9f72-20cc4f57b10c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSNc3a08907-778d-4229-9f72-20cc4f57b10c2
310467gentamicin 3 MG/ML Ophthalmic SolutionSCDc3a08907-778d-4229-9f72-20cc4f57b10c2
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSYc3a08907-778d-4229-9f72-20cc4f57b10c2
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSYc3a08907-778d-4229-9f72-20cc4f57b10c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50436-6752-15043667520115 mL in 1 BOTTLE, DROPPER15 mlHistorical