JAKAFI (Page 12 of 12)

5 mg Tablet Bottle Label

Rx only

NDC 50881-005-60

Jakafi® (Ruxolitinib) Tablets

5 mg

60 tablets

Each tablet contains 6.6 mg ruxolitinib phosphate equivalent to 5 mg ruxolitinib free base.

Jakafi (Ruxolitinib) 5mg Tablets -- 60 Tablet Bottle Label
(click image for full-size original)

10 mg Tablet Bottle Label

Rx only

NDC 50881-010-60

Jakafi® (Ruxolitinib) Tablets

10 mg

60 tablets

Each tablet contains 13.2 mg ruxolitinib phosphate equivalent to 10 mg ruxolitinib free base.

Jakafi (Ruxolitinib) 10mg Tablets -- 60 Tablet Bottle Label
(click image for full-size original)

15 mg Tablet Bottle Label

Rx only

NDC 50881-015-60

Jakafi® (Ruxolitinib) Tablets

15 mg

60 tablets

Each tablet contains 19.8 mg ruxolitinib phosphate equivalent to 15 mg ruxolitinib free base.

Jakafi (Ruxolitinib) 15mg Tablets -- 60 Tablet Bottle Label
(click image for full-size original)

20 mg Tablet Bottle Label

Rx only

NDC 50881-020-60

Jakafi® (Ruxolitinib) Tablets

20 mg

60 tablets

Each tablet contains 26.4 mg ruxolitinib phosphate equivalent to 20 mg ruxolitinib free base.

Jakafi (Ruxolitinib) 20mg Tablets -- 60 Tablet Bottle Label
(click image for full-size original)

25 mg Tablet Bottle Label

Rx only

NDC 50881-025-60

Jakafi® (Ruxolitinib) Tablets

25 mg

60 tablets

Each tablet contains 33 mg ruxolitinib phosphate equivalent to 25 mg ruxolitinib free base.

Jakafi (Ruxolitinib) 25mg Tablets -- 60 Tablet Bottle Label
(click image for full-size original)
JAKAFI ruxolitinib tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50881-005
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUXOLITINIB (RUXOLITINIB) RUXOLITINIB 5.0 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE (70000 WAMW)
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color white (White to off-white) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code INCY;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50881-005-60 60 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202192 11/16/2011
JAKAFI ruxolitinib tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50881-010
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUXOLITINIB (RUXOLITINIB) RUXOLITINIB 10.0 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE (70000 WAMW)
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color white (White to off-white) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code INCY;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50881-010-01 28 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:50881-010-60 60 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202192 11/16/2011
JAKAFI ruxolitinib tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50881-015
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUXOLITINIB (RUXOLITINIB) RUXOLITINIB 15.0 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE (70000 WAMW)
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color white (White to off-white) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code INCY;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50881-015-60 60 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202192 11/16/2011
JAKAFI ruxolitinib tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50881-020
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUXOLITINIB (RUXOLITINIB) RUXOLITINIB 20.0 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE (70000 WAMW)
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color white (White to off-white) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code INCY;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50881-020-60 60 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202192 11/16/2011
JAKAFI ruxolitinib tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50881-025
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUXOLITINIB (RUXOLITINIB) RUXOLITINIB 25.0 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE (70000 WAMW)
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color white (White to off-white) Score no score
Shape OVAL Size 18mm
Flavor Imprint Code INCY;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50881-025-60 60 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202192 11/16/2011
Labeler — Incyte Corporation (556967347)

Revised: 01/2023 Incyte Corporation

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