TOBI Podhaler

Product NDC
0078-0630
11-digit product format
000780630
Labeler code
0078
Product ID
0078-0630_ad4249f8-4192-4887-8cf3-28f90e67a280
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
CAPSULE
Route
ORAL; RESPIRATORY (INHALATION)
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA201688
Marketing category
NDA
Marketing start
2013-03-22
Marketing end
2022-07-31
Substance
TOBRAMYCIN
Active strength
28 mg/1
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
0078-0630-11EA - Each0078-0630bdcd60f2-d7ce-44f8-9dc5-6d9ad69fd41712013-05-02
0078-0630-19EA - Each0078-0630edfa1a78-7c15-437f-8c76-597abc592e4f12015-05-05
0078-0630-35EA - Each0078-063088c8485a-4212-4b7a-81fd-dfe22f6506ed12013-04-01
0078-0630-56EA - Each0078-0630237e5625-786a-4c89-99e2-e5c3fd491dfd12013-04-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0630-3500078063035224 PACKAGE in 1 BOX, UNIT-DOSE (0078-0630-35) > 56 BLISTER PACK in 1 PACKAGE (0078-0630-56) > 4 CAPSULE in 1 BLISTER PACK (0078-0630-11) 224 package2013-03-222022-07-31NoNoCurrent