GENTAMICIN SULFATE

Product NDC
21695-187
11-digit product format
216950187
Labeler code
21695
Product ID
21695-187_d7a27e38-0553-4d4b-8438-fed235e9b989
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gentamicin sulfate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Rebel Distributors Corp
Application
ANDA062452
Marketing category
ANDA
Marketing start
1984-10-10
Marketing end
0000-00-00
Substance
GENTAMICIN SULFATE
Active strength
3 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-187-05GENTAMICIN SULFATE5 mL in 1 BOTTLE, DROPPERSOLUTION51
21695-187-15GENTAMICIN SULFATE15 mL in 1 BOTTLE, DROPPERSOLUTION151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-187-05ML - Milliliter21695-187c9328ed0-4711-4732-a4e2-d0e11c2a4c4712012-07-24
21695-187-15ML - Milliliter21695-1875e7a5432-44af-4f31-94bf-c92570fefdbf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
gentamicin sulfateACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]1
gentamicinACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KGENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBGENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XGENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IGENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RGENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-187GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20101126_d7a27e38-0553-4d4b-8438-fed235e9b989.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSNd7a27e38-0553-4d4b-8438-fed235e9b9891
310467gentamicin 3 MG/ML Ophthalmic SolutionSCDd7a27e38-0553-4d4b-8438-fed235e9b9891
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSYd7a27e38-0553-4d4b-8438-fed235e9b9891
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSYd7a27e38-0553-4d4b-8438-fed235e9b9891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-187-05216950187055 mL in 1 BOTTLE, DROPPER5 mlHistorical
21695-187-152169501871515 mL in 1 BOTTLE, DROPPER15 mlHistorical