Tobramycin

Product NDC
68788-8248
11-digit product format
687888248
Labeler code
68788
Product ID
68788-8248_1ff5edfb-18ae-4622-83fe-a6946f484016
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA064052
Marketing category
ANDA
Marketing start
2022-08-19
Marketing end
0000-00-00
Substance
TOBRAMYCIN
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
68788-8248-5ML - Milliliter68788-824828cfed67-5c70-4122-af05-872482ac550612022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8248TOBRAMYCIN SOLUTION [PREFERRED PHARMACEUTICALS INC.]3Legacy NDC20240822_1ff5edfb-18ae-4622-83fe-a6946f484016.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8248-5687888248051 BOTTLE, DROPPER in 1 CARTON (68788-8248-5) > 5 mL in 1 BOTTLE, DROPPER2022-08-190000-00-00NoNoCurrent