SYMDEKO (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — Kit Carton

Rx Only
NDC 51167-661-01

symdeko®
(tezacaftor/ivacaftor) 100 mg/150 mg
and (ivacaftor) 150 mg tablets

56 tablets
Contains 4-week supply of SYMDEKO
4 weekly blister cards, each with 14 tablets:(7 tezacaftor/ivacaftor and 7 ivacaftor tablets)

LIFT HERE TO OPEN ▶

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Kit Carton — 113

Rx Only
NDC 51167-113-01

symdeko®

(tezacaftor/ivacaftor) 50 mg/75 mg
and (ivacaftor) 75 mg tablets

56 tablets

Contains 4-week supply of SYMDEKO
4 weekly blister cards, each with 14 tablets:(7 tezacaftor/ivacaftor and 7 ivacaftor tablets)

LIFT HERE TO OPEN ▶

PRINCIPAL DISPLAY PANEL -- Kit Carton -- 113
(click image for full-size original)
SYMDEKO tezacaftor and ivacaftor kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51167-661
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51167-661-01 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 4 BLISTER PACK 28
Part 2 4 BLISTER PACK 28
Part 1 of 2
TEZACAFTOR AND IVACAFTOR tezacaftor and ivacaftor tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tezacaftor (Tezacaftor) Tezacaftor 100 mg
Ivacaftor (Ivacaftor) Ivacaftor 150 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)
Sodium lauryl sulfate
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
Croscarmellose sodium
MAGNESIUM STEARATE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Titanium dioxide
Talc
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code V100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 7 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210491 02/12/2018
Part 2 of 2
IVACAFTOR ivacaftor tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ivacaftor (Ivacaftor) Ivacaftor 150 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
CARNAUBA WAX
FD&C Blue No. 2
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
AMMONIA
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 17mm
Flavor Imprint Code V;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 7 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210491 02/12/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210491 02/12/2018
SYMDEKO tezacaftor and ivacaftor kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51167-113
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51167-113-01 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 4 BLISTER PACK 28
Part 2 4 BLISTER PACK 28
Part 1 of 2
TEZACAFTOR AND IVACAFTOR tezacaftor and ivacaftor tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tezacaftor (Tezacaftor) Tezacaftor 50 mg
Ivacaftor (Ivacaftor) Ivacaftor 75 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)
Sodium lauryl sulfate
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
Croscarmellose sodium
MAGNESIUM STEARATE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Titanium dioxide
Talc
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 13mm
Flavor Imprint Code V50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 7 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210491 06/21/2019
Part 2 of 2
IVACAFTOR ivacaftor tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ivacaftor (Ivacaftor) Ivacaftor 75 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
CARNAUBA WAX
FD&C Blue No. 2
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
AMMONIA
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 13mm
Flavor Imprint Code V;75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 7 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210491 06/21/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210491 06/21/2019
Labeler — Vertex Pharmaceuticals Incorporated (602478257)

Revised: 06/2022 Vertex Pharmaceuticals Incorporated

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.