Gentamicin Sulfate

Product NDC
13985-603
11-digit product format
139850603
Labeler code
13985
Product ID
13985-603_40278cbf-031b-484d-8d2d-4ddbcf24219b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
MWI
Application
ANDA064163
Marketing category
ANDA
Marketing start
2015-03-23
Marketing end
0000-00-00
Substance
GENTAMICIN SULFATE
Active strength
3 mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13985-603-03139850603031 TUBE in 1 CARTON (13985-603-03) > 3.5 g in 1 TUBE1 tube2015-03-230000-00-00NoNoCurrent