Tobramycin Inhalation Solution

Product NDC
65302-063
11-digit product format
653020063
Labeler code
65302
Product ID
65302-063_f05e4685-c086-90e3-e053-2995a90a5cd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
The Ritedose Corporation
Application
ANDA201422
Marketing category
ANDA
Marketing start
2014-05-29
Marketing end
0000-00-00
Substance
TOBRAMYCIN
Active strength
300 mg/5mL
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
65302-063-046530200630414 POUCH in 1 CARTON (65302-063-04) > 4 AMPULE in 1 POUCH > 5 mL in 1 AMPULE14 pouch2014-05-290000-00-00NoNoCurrent