teduglutide injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68875-0101
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
teduglutide (UNII: 7M19191IKG) (teduglutide - UNII:7M19191IKG) teduglutide 5 mg in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
Histidine (UNII: 4QD397987E) 3.88 mg in 0.5 mL
mannitol (UNII: 3OWL53L36A) 15 mg in 0.5 mL
sodium phosphate, monobasic, monohydrate (UNII: 593YOG76RN) 0.644 mg in 0.5 mL
sodium phosphate, dibasic, heptahydrate (UNII: 70WT22SF4B) 3.434 mg in 0.5 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68875-0101-2 30 in 1 CARTON 12/21/2012
1 NDC:68875-0101-1 0.5 mL in 1 VIAL; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203441 12/21/2012
GATTEX
teduglutide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68875-0103
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68875-0103-1 1 in 1 CARTON 12/21/2012
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 0.5 mL
Part 2 1 SYRINGE, PLASTIC 0.5 mL
Part 3 4 PACKET 2.8 mL
Part 1 of 3
GATTEX
teduglutide injection, powder, lyophilized, for solution
Product Information
Item Code (Source) NDC:68875-0101
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
teduglutide (UNII: 7M19191IKG) (teduglutide - UNII:7M19191IKG) teduglutide 5 mg in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
histidine (UNII: 4QD397987E) 3.88 mg in 0.5 mL
mannitol (UNII: 3OWL53L36A) 15 mg in 0.5 mL
sodium phosphate, monobasic, monohydrate (UNII: 593YOG76RN) 0.644 mg in 0.5 mL
sodium phosphate, dibasic, heptahydrate (UNII: 70WT22SF4B) 3.434 mg in 0.5 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68875-0101-1 0.5 mL in 1 VIAL; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203441 12/21/2012
Part 2 of 3
WATER
sterile water liquid
Product Information
Route of Administration SUBCUTANEOUS
Inactive Ingredients
Ingredient Name Strength
water (UNII: 059QF0KO0R) 0.5 mL in 0.5 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 0.5 mL in 1 SYRINGE, PLASTIC; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203441 12/21/2012
Part 3 of 3
PDI ALCOHOL PREP PAD STERILE
alcohol swab
Product Information
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol 0.7 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
water (UNII: 059QF0KO0R) 0 |
