PREZISTA (Page 12 of 12)

PRINCIPAL DISPLAY PANEL — 75 mg Tablet Bottle Label

480 Tablets
Rx only

NDC 59676-563-01

PREZISTA®
(darunavir) tablets

75 mg

ALERT
Find out about
medicines that
should NOT be taken with PREZISTA.

janssen

PRINCIPAL DISPLAY PANEL -- 75 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 150 mg Tablet Bottle Label

240 Tablets Rx only

NDC 59676-564-01

PREZISTA®
(darunavir) tablets

150 mg

ALERT
Find out about
medicines that
should NOT be taken with PREZISTA.

janssen

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

PRINCIPAL DISPLAY PANEL — 600 mg Tablet Bottle Label

60 Tablets Rx only

NDC 59676-562-01

PREZISTA®
(darunavir) tablets

600 mg

ALERT
Find out about
medicines that
should NOT be taken with PREZISTA.

janssen

PRINCIPAL DISPLAY PANEL -- 600 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 800 mg Tablet Bottle Label

30 Tablets Rx only

NDC 59676-566-30

PREZISTA®
(darunavir) tablets

800 mg

ALERT
Find out about medicines that
should NOT be taken with PREZISTA.

janssen

PRINCIPAL DISPLAY PANEL -- 800 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mL Bottle Carton

200 mL
NDC 59676-565-01

PREZISTA®
(darunavir) Oral Suspension

100 mg per mL

Store at 25°C (77°F); with excursions
permitted to 15°-30°C (59°-86°F).

Do not refrigerate or freeze.

Shake well before each usage.

RECOMMENDED DOSAGE: See
Prescribing Information

Dispensing: For information concerning
proper usage of the oral dosing syringe,
see accompanying patient instructions.

Keep out of reach of children.

ALERT
Find out about medicines that
should NOT be taken withPREZISTA.

Rx only

janssen

PRINCIPAL DISPLAY PANEL -- 200 mL Bottle Carton
(click image for full-size original)
PREZISTA darunavir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-563
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
darunavir ethanolate (darunavir) darunavir 75 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
CROSPOVIDONE (120 .MU.M)
magnesium stearate
microcrystalline cellulose
polyethylene glycol 3350
polyvinyl alcohol, unspecified
talc
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape OVAL (caplet-shaped) Size 9mm
Flavor Imprint Code 75;TMC
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-563-01 480 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021976 01/14/2009
PREZISTA darunavir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-564
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
darunavir ethanolate (darunavir) darunavir 150 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
CROSPOVIDONE (120 .MU.M)
magnesium stearate
microcrystalline cellulose
polyethylene glycol 3350
polyvinyl alcohol, unspecified
talc
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape OVAL (oval-shaped) Size 14mm
Flavor Imprint Code 150;TMC
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-564-01 240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021976 04/27/2009
PREZISTA darunavir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-562
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
darunavir ethanolate (darunavir) darunavir 600 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
CROSPOVIDONE (120 .MU.M)
magnesium stearate
microcrystalline cellulose
FD&C Yellow No. 6
polyethylene glycol 3350
polyvinyl alcohol, unspecified
talc
titanium dioxide
Product Characteristics
Color ORANGE Score no score
Shape OVAL (oval-shaped) Size 21mm
Flavor Imprint Code 600MG;TMC
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-562-01 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021976 03/08/2008
PREZISTA darunavir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-566
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
darunavir ethanolate (darunavir) darunavir 800 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
CROSPOVIDONE (120 .MU.M)
magnesium stearate
microcrystalline cellulose
hypromellose, unspecified
polyethylene glycol 3350
polyvinyl alcohol, unspecified
talc
titanium dioxide
FERRIC OXIDE RED
Product Characteristics
Color RED (dark red) Score no score
Shape OVAL (oval-shaped) Size 20mm
Flavor Imprint Code 800;T
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-566-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021976 11/09/2012
PREZISTA darunavir suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-565
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
darunavir ethanolate (darunavir) darunavir 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
microcrystalline cellulose
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
METHYLPARABEN SODIUM
CITRIC ACID MONOHYDRATE
SUCRALOSE
HYDROCHLORIC ACID
WATER
STRAWBERRY
Product Characteristics
Color WHITE (white to off-white opaque) Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-565-01 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 200 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (59676-565-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202895 12/16/2011
Labeler — Janssen Products LP (804684207)
Establishment
Name Address ID/FEI Operations
JANSSEN ORTHO LLC 805887986 ANALYSIS (59676-563), ANALYSIS (59676-564), ANALYSIS (59676-562), ANALYSIS (59676-565), ANALYSIS (59676-566), MANUFACTURE (59676-563), MANUFACTURE (59676-564), MANUFACTURE (59676-562), MANUFACTURE (59676-566)
Establishment
Name Address ID/FEI Operations
Cilag AG 483237103 API MANUFACTURE (59676-563), API MANUFACTURE (59676-564), API MANUFACTURE (59676-562), API MANUFACTURE (59676-565), API MANUFACTURE (59676-566)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutical Sciences Unlimited Company 985639841 API MANUFACTURE (59676-563), API MANUFACTURE (59676-564), API MANUFACTURE (59676-562), API MANUFACTURE (59676-565), API MANUFACTURE (59676-566)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceuticals, Inc 063137772 ANALYSIS (59676-563), ANALYSIS (59676-564), ANALYSIS (59676-562), ANALYSIS (59676-565), ANALYSIS (59676-566)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutica NV 370005019 MANUFACTURE (59676-565), ANALYSIS (59676-565)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutica NV 400345889 API MANUFACTURE (59676-565)
Establishment
Name Address ID/FEI Operations
Janssen Cilag SpA 542797928 MANUFACTURE (59676-562), MANUFACTURE (59676-566), MANUFACTURE (59676-563), MANUFACTURE (59676-564), ANALYSIS (59676-562), ANALYSIS (59676-566), ANALYSIS (59676-563), ANALYSIS (59676-564)

Revised: 07/2021 Janssen Products LP

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