Gentamicin Sulfate

Product NDC
68788-7336
11-digit product format
687887336
Labeler code
68788
Product ID
68788-7336_3975c312-d90e-459b-bcca-5a467955201c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA062196
Marketing category
ANDA
Marketing start
2019-03-12
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
68788-7336-5ML - Milliliter68788-733604391969-ed5f-436e-93e5-c842d9d5405912019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7336GENTAMICIN SULFATE SOLUTION [PREFERRED PHARMACEUTICALS INC.]6Legacy NDC20250115_f91d8769-81b0-4907-b908-202f22289a89.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7336-5687887336055 mL in 1 BOTTLE, PLASTIC (68788-7336-5) 5 ml2019-03-120000-00-00NoNoCurrent