Gentamicin Sulfate

Product NDC
53002-9291
11-digit product format
530029291
Labeler code
53002
Product ID
53002-9291_46507b73-1131-479b-9a42-13bd2aece374
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA062196
Marketing category
ANDA
Marketing start
1996-04-05
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
2021-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
8X7386QRLVGENTAMICIN SULFATE1405-41-0GENTAMICIN SULFATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-9291-1530029291015 mL in 1 BOTTLE, DROPPER (53002-9291-1) 5 ml2019-01-010000-00-00NoNoCurrent