TOBI

Product NDC
0078-0494
11-digit product format
000780494
Labeler code
0078
Product ID
0078-0494_f06e22f8-0326-4686-bbb5-22c5d94ef887
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA050753
Marketing category
NDA
Marketing start
1997-12-22
Marketing end
2022-12-31
Substance
TOBRAMYCIN
Active strength
300 mg/5mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0494-61ML - Milliliter0078-0494b30c2f2a-a42b-48f2-9558-b6b65f9b3e7112012-07-24
0078-0494-71ML - Milliliter0078-04942a2958c9-584d-4740-b49f-4d78ebd5294012012-07-24
0078-0494-91ML - Milliliter0078-0494c1fbfc55-5e38-476b-b649-2ee8f9c2fa7312022-06-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0494-710007804947156 POUCH in 1 CARTON (0078-0494-71) > 4 AMPULE in 1 POUCH (0078-0494-91) > 5 mL in 1 AMPULE (0078-0494-61) 56 pouch1997-12-220000-00-00NoNoCurrent