EDURANT (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 25 mg Tablet Bottle Label

30 Tablets
NDC 59676-278-01

EDURANT ®
(rilpivirine) tablets

25 mg

Each tablet contains 27.5 mg of rilpivirine
hydrochloride, which is equivalent to 25 mg
of rilpivirine.

ALERT: Find out about
medicines that should NOT be
taken with EDURANT® fromyour healthcare provider.

Rx only

PRINCIPAL DISPLAY PANEL -- 25 mg Tablet Bottle Label
(click image for full-size original)
EDURANT rilpivirine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-278
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
rilpivirine hydrochloride (rilpivirine) rilpivirine 25 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
LACTOSE MONOHYDRATE
POVIDONE K30
POLYSORBATE 20
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 3000
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE (white to off white) Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code TMC;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-278-01 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202022 05/20/2011
Labeler — Janssen Products, LP (804684207)
Establishment
Name Address ID/FEI Operations
Janssen-Cilag SpA 542797928 MANUFACTURE (59676-278), ANALYSIS (59676-278)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutica NV 400345889 API MANUFACTURE (59676-278)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutical Sciences Unlimited Company 985639841 API MANUFACTURE (59676-278)
Establishment
Name Address ID/FEI Operations
AndersonBrecon Inc 053217022 LABEL (59676-278), PACK (59676-278)

Revised: 02/2021 Janssen Products, LP

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