RUVICA that is written for health professionals.
What are the ingredients in IMBRUVICA?
Active ingredient: ibrutinib
Inactive ingredients:
IMBRUVICA capsules: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The 70 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, and black ink. The 140 mg capsule shell contains gelatin, titanium dioxide, and black ink.
IMBRUVICA tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating for each tablet contains ferrosoferric oxide (140 mg, 280 mg, and 420 mg tablets), polyvinyl alcohol, polyethylene glycol, red iron oxide (280 mg and 560 mg tablets), talc, titanium dioxide, and yellow iron oxide (140 mg, 420 mg, and 560 mg tablets).
Distributed and Marketed by: Pharmacyclics LLC Sunnyvale, CA USA 94085
Marketed by: Janssen Biotech, Inc. Horsham, PA USA 19044.
© Pharmacyclics LLC 2018
© Janssen Biotech, Inc. 2018
For more information, go to www.imbruvica.com or call 1-877-877-3536.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 02/2018CLOSE
PRINCIPAL DISPLAY PANEL - 28 CAPSULE BOTTLE CARTON
NDC 57962-070-28
Imbruvica®
(ibrutinib) capsules
70 mg
Each capsule contains: ibrutinib 70 mg
Swallow capsules whole with water
28 Capsules
Rx Only
Pharmacyclics LLC
An AbbVie Company
Janssen Biotech, Inc.
PRINCIPAL DISPLAY PANEL - 28 Capsule Bottle Carton
PRINCIPAL DISPLAY PANEL - 28 CAPSULE BOTTLE LABEL
NDC 57962-070-28
Imbruvica®
(ibrutinib) capsules
70 mg
Each capsule contains: ibrutinib 70 mg
Swallow capsules whole with water
28 Capsules
Rx Only
Pharmacyclics LLC
An AbbVie Company
Janssen Biotech, Inc.
PRINCIPAL DISPLAY PANEL - 28 Capsule Bottle Label
PRINCIPAL DISPLAY PANEL - 90 CAPSULE BOTTLE CARTON
NDC 57962-140-09
Imbruvica®
(ibrutinib) capsules
140 mg
Each capsule contains: ibrutinib 140 mg
Swallow capsules whole with water
90 Capsules
Rx Only
Pharmacyclics LLC
An AbbVie Company
Janssen Biotech, Inc.
PRINCIPAL DISPLAY PANEL - 90 Capsule Bottle Carton
PRINCIPAL DISPLAY PANEL - 120 CAPSULE BOTTLE CARTON
NDC 57962-140-12
Imbruvica®
(ibrutinib) capsules
140 mg
Each capsule contains: ibrutinib 140 mg
Swallow capsules whole with water
120 Capsules
Rx Only
Pharmacyclics LLC
An AbbVie Company
Janssen Biotech, Inc.
PRINCIPAL DISPLAY PANEL - 120 Capsule Bottle Carton
PRINCIPAL DISPLAY PANEL - 28 TABLET BLISTER CARTON
NDC 57962-014-28
Imbruvica®
(ibrutinib) tablets
140 mg
Each table contains: ibrutinib 140 mg
Swallow tablet whole with water
28 Tablets
Rx Only
Pharmacyclics LLC
An AbbVie Company
Janssen Biotech, Inc.
PRINCIPAL DISPLAY PANEL - 28 Tablet Blister Carton
PRINCIPAL DISPLAY PANEL - 28 TABLET BLISTER STRIP (FRONT)
NDC 57962-014-28
Imbruvica®
(ibrutinib) tablets
140 mg
Each table contains: ibrutinib 140 mg
Swallow tablet whole with water
28 Tablets
Rx Only
Pharmacyclics LLC
An AbbVie Company
Janssen Biotech, Inc.
PRINCIPAL DISPLAY PANEL - 28 Tablet Blister Strip (Front)
PRINCIPAL DISPLAY PANEL - 28 TABLET BLISTER STRIP (BACK)
NDC |