Atripla (Page 12 of 12)

ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. EMTRIVA, TRUVADA, HEPSERA and VIREAD are trademarks of Gilead Sciences, Inc. SUSTIVA is a trademark of Bristol-Myers Squibb Pharma Company. Reyataz and Videx are trademarks of Bristol-Myers Squibb Company. Pravachol is a trademark of ER Squibb & Sons, LLC. Other brands listed are the trademarks of their respective owners.

This product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

PRINCIPAL DISPLAY PANEL — 30 Tablet Blister Pack

NDC 53808-0208-1

ATRIPLA®

(efavirenz 600 mg/emtricitabine 200 mg/
tenofovir disoproxil fumarate 300 mg)
Tablets

30 tablets

Note to pharmacist: Do not cover ALERT box with pharmacy label.

ALERT: Find out about medicines that should NOT be taken with ATRIPLA®

PRINCIPAL DISPLAY PANEL -- 30 Tablet Blister Pack
(click image for full-size original)
ATRIPLA efavirenz, emtricitabine, and tenofovir disoproxil fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-0208(NDC:15584-0101)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EFAVIRENZ (efavirenz) EFAVIRENZ 600 mg
EMTRICITABINE (emtricitabine) EMTRICITABINE 200 mg
TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR ANHYDROUS) TENOFOVIR DISOPROXIL FUMARATE 300 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (TYPE H)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
FERRIC OXIDE RED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color PINK Score no score
Shape OVAL Size 20mm
Flavor Imprint Code 123
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53808-0208-1 30 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021937 07/01/2009
Labeler — DOH CENTRAL PHARMACY (829348114)
Establishment
Name Address ID/FEI Operations
DOH CENTRAL PHARMACY 829348114 repack (53808-0208)

Revised: 01/2017 DOH CENTRAL PHARMACY

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