Kalydeco (Page 11 of 11)

PRINCIPAL DISPLAY PANEL — 150 mg Tablet Blister Card Carton

NDC 51167-200-01
Rx only

kalydeco®
(ivacaftor) tablets

150 mg per tablet

Carton contains
4 individual blister cards of 14 tablets per card.

56 tablets

PRINCIPAL DISPLAY PANEL -- 150 mg Tablet Blister Card Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 150 mg Tablet Bottle Carton

NDC 51167-200-02
Rx only

kalydeco™ (ivacaftor) tablets

150 mg

60 tablets

PRINCIPAL DISPLAY PANEL -- 150 mg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg Granule Packet Carton

Rx only
NDC 51167-300-01

kalydeco®
(ivacaftor) oral granules

50 mg

56 packets
Each packet contains 50 mg ivacaftor

Carton contains: 4 individual wallets with 14 packets per wallet

Lift here to open

PRINCIPAL DISPLAY PANEL -- 50 mg Granule Packet Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 75 mg Granule Packet Carton

Rx only
NDC 51167-400-01

kalydeco®
(ivacaftor) oral granules

75 mg

56 packets
Each packet contains 75 mg ivacaftor

Carton contains: 4 individual wallets with 14 packets per wallet

Lift here to open

PRINCIPAL DISPLAY PANEL -- 75 mg Granule Packet Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 mg Granule Packet Carton

Rx only
NDC 51167-600-01

kalydeco®
(ivacaftor) oral granules

25 mg

56 packets
Each packet contains 25 mg ivacaftor

Carton contains: 4 individual wallets wtih 14 packets per wallet

Lift here to open

PRINCIPAL DISPLAY PANEL -- 25 mg Granule Packet Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 13.4 mg Granule Packet Carton

Rx only
NDC 51167-770-01

kalydeco®
(ivacaftor) oral granules

13.4 mg

56 packets
Each packet contains 13.4 mg ivacaftor

Carton contains: 4 individual walletswith 14 packets per wallet

Lift here to open

PRINCIPAL DISPLAY PANEL -- 13.4 mg Granule Packet Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5.8 mg Granule Packet Carton

Rx only
NDC 51167-785-01

kalydeco®
(ivacaftor) oral granules

5.8 mg

56 packets
Each packet contains 5.8 mg ivacaftor

Carton contains: 4 individual walletswith 14 packets per wallet

Lift here to open

PRINCIPAL DISPLAY PANEL -- 5.8 mg Granule Packet Carton
(click image for full-size original)
KALYDECO ivacaftor tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51167-200
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 5mm
Flavor Imprint Code V;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51167-200-01 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 14 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (51167-200-01)
2 NDC:51167-200-02 1 BOTTLE in 1 CARTON contains a BOTTLE
2 60 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (51167-200-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203188 01/31/2012
KALYDECO ivacaftor granule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51167-300
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ivacaftor (ivacaftor) ivacaftor 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MANNITOL
SUCRALOSE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51167-300-01 56 GRANULE in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207925 03/23/2015
KALYDECO ivacaftor granule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51167-400
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
MANNITOL
SUCRALOSE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51167-400-01 56 GRANULE in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207925 03/23/2015
KALYDECO ivacaftor granule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51167-600
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ivacaftor (ivacaftor) ivacaftor 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MANNITOL
SUCRALOSE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51167-600-01 56 GRANULE in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207925 04/29/2019
KALYDECO ivacaftor granule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51167-770
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ivacaftor (ivacaftor) ivacaftor 13.4 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SUCRALOSE
SODIUM LAURYL SULFATE
MANNITOL
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51167-770-01 56 GRANULE in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207925 05/03/2023
KALYDECO ivacaftor granule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51167-785
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ivacaftor (ivacaftor) ivacaftor 5.8 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SUCRALOSE
SODIUM LAURYL SULFATE
MANNITOL
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51167-785-01 56 GRANULE in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207925 05/03/2023
Labeler — Vertex Pharmaceuticals Incorporated (602478257)
Establishment
Name Address ID/FEI Operations
Vertex Pharmaceuticals Incorporated 602478257 ANALYSIS (51167-200), ANALYSIS (51167-300), ANALYSIS (51167-400), ANALYSIS (51167-600), ANALYSIS (51167-770), ANALYSIS (51167-785)

Revised: 10/2023 Vertex Pharmaceuticals Incorporated

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