Intelence (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 100 mg Tablet Bottle Label

120 Tablets
NDC 59676-570-01

INTELENCE®
(etravirine) tablets

100 mg

Each tablet contains
100 mg of etravirine.

Rx only

janssen

ALERT: Find out about medicines that
should NOT be taken with INTELENCE® from your healthcare provider.

PRINCIPAL DISPLAY PANEL -- 100 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mg Tablet Bottle Label

60 Tablets
NDC 59676-571-01

INTELENCE®
(etravirine) tablets

200 mg

Each tablet contains
200 mg of etravirine.

Rx only

janssen

ALERT: Find out about medicines that
should NOT be taken with INTELENCE® from your healthcare provider.

PRINCIPAL DISPLAY PANEL -- 200 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 mg Tablet Bottle Label

120 Tablets
NDC 59676-572-01

INTELENCE®
(etravirine) tablets

25 mg

Each tablet contains 25 mg of etravirine.

Rx only

ALERT: Find out about medicines that
should NOT be taken with INTELENCE® from your healthcare provider.

PRINCIPAL DISPLAY PANEL -- 25 mg Tablet Bottle Label
(click image for full-size original)
INTELENCE etravirine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-570
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
etravirine (etravirine) etravirine 100 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
croscarmellose sodium
hypromellose, unspecified
lactose monohydrate
magnesium stearate
microcrystalline cellulose
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code TMC125;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-570-01 120 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022187 01/18/2008
INTELENCE etravirine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-571
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
etravirine (etravirine) etravirine 200 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
croscarmellose sodium
hypromellose, unspecified
magnesium stearate
microcrystalline cellulose
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL (biconvex, oblong) Size 22mm
Flavor Imprint Code T200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-571-01 60 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022187 12/22/2010
INTELENCE etravirine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-572
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
etravirine (etravirine) etravirine 25 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
croscarmellose sodium
hypromellose, unspecified
lactose monohydrate
magnesium stearate
microcrystalline cellulose
Product Characteristics
Color WHITE (white to off white) Score 2 pieces
Shape OVAL Size 12mm
Flavor Imprint Code TMC
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-572-01 120 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022187 03/26/2012
Labeler — Janssen Products LP (804684207)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutica NV 400345889 API MANUFACTURE (59676-570), API MANUFACTURE (59676-571), API MANUFACTURE (59676-572), ANALYSIS (59676-570), ANALYSIS (59676-571), ANALYSIS (59676-572)
Establishment
Name Address ID/FEI Operations
Janssen Cilag SpA 542797928 MANUFACTURE (59676-570), MANUFACTURE (59676-571), MANUFACTURE (59676-572), ANALYSIS (59676-570), ANALYSIS (59676-571), ANALYSIS (59676-572)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutica NV 370005019 ANALYSIS (59676-570), ANALYSIS (59676-571), ANALYSIS (59676-572)
Establishment
Name Address ID/FEI Operations
Johnson and Johnson Private Limited 677603030 ANALYSIS (59676-570), ANALYSIS (59676-571), ANALYSIS (59676-572)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceuticals, Inc 063137772 ANALYSIS (59676-570), ANALYSIS (59676-571), ANALYSIS (59676-572)
Establishment
Name Address ID/FEI Operations
JANSSEN ORTHO LLC 805887986 MANUFACTURE (59676-571), ANALYSIS (59676-571)

Revised: 10/2020 Janssen Products LP

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