PREZCOBIX (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 800 mg/150 mg Tablet Bottle Label

NDC 59676-575-30

PREZCOBIX®
(darunavir and cobicistat)
Tablets

800 mg/150 mg

Each tablet contains darunavir
ethanolate (equivalent to
800 mg of darunavir) and
150 mg cobicistat.

Keep out of reach of children

Rx only 30 Tablets

PRINCIPAL DISPLAY PANEL -- 800 mg/150 mg Tablet Bottle Label
(click image for full-size original)
PREZCOBIX darunavir ethanolate and cobicistat tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-575
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DARUNAVIR ETHANOLATE (DARUNAVIR) DARUNAVIR 800 mg
COBICISTAT (COBICISTAT) COBICISTAT 150 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
Product Characteristics
Color PINK Score no score
Shape OVAL Size 23mm
Flavor Imprint Code 800;TG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-575-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205395 01/31/2015
Labeler — Janssen Products LP (804684207)
Establishment
Name Address ID/FEI Operations
Cilag AG 483237103 API MANUFACTURE (59676-575)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutical Sciences Unlimited Company 985639841 API MANUFACTURE (59676-575)
Establishment
Name Address ID/FEI Operations
Janssen Ortho LLC 805887986 MANUFACTURE (59676-575), ANALYSIS (59676-575)
Establishment
Name Address ID/FEI Operations
Gilead Alberta ULC 207452996 API MANUFACTURE (59676-575)
Establishment
Name Address ID/FEI Operations
Yuhan Chemical Inc. 687831958 MANUFACTURE (59676-575)

Revised: 07/2021 Janssen Products LP

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