4 weekly packs x 56 capsules per pack
For Oral Inhalation Only
Do not swallow TOBI® Podhaler™ capsules
TOBI® Podhaler™ capsules are for use with the Podhaler™ device only
Contents:
4 weekly packs, each containing:
56 capsules (7 blister cards of 8 capsules)
1 Podhaler™ device
Patient information leaflet
1 Reserve Podhaler™ device
Prescribing Information
TOBI PODHALER
tobramycin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0630
Route of Administration ORAL, RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOBRAMYCIN (TOBRAMYCIN) TOBRAMYCIN 28 mg
Inactive Ingredients
Ingredient Name Strength
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE
CALCIUM CHLORIDE
SULFURIC ACID
Product Characteristics
Color WHITE (clear, colorless) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code NVR;AVCI
Contains
Packaging
# Item Code Package Description
1 NDC:0078-0630-35 224 in 1 BOX, UNIT-DOSE
1 NDC:0078-0630-56 56 in 1 PACKAGE
1 NDC:0078-0630-11 4 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201688 03/22/2013
Labeler - Novartis Pharmaceuticals Corporation (002147023)
Revised: 03/2013
Document Id: ff8c7c8d-7396-4e03-b84e-efadb3e28cd0
Set id: 625a4499-4e46-4f5a-8d0c-d104f520d97e
Version: 1
Effective Time: 20130322
