GENTAMICIN SULFATE

Product NDC
63187-163
11-digit product format
631870163
Labeler code
63187
Product ID
63187-163_9bc97257-3fe5-45aa-a544-78d044982cd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gentamicin sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Proficient Rx LP
Application
ANDA062452
Marketing category
ANDA
Marketing start
1998-01-05
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-163-05ML - Milliliter63187-1632c61686e-8569-4a5b-b17e-baf4ff13006112016-04-04

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-163GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]4Legacy NDC20220722_3ab508ed-4b12-4dd7-a13e-1a071f560286.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-163-05631870163051 BOTTLE, DROPPER in 1 CARTON (63187-163-05) > 5 mL in 1 BOTTLE, DROPPER2019-01-010000-00-00NoNoCurrent