SUSTIVA (Page 10 of 10)

NDC 54868-4668-0 30 Tablets

SUSTIVA ® Rx only
(efavirenz) tablets

600 mg

Each tablet contains 600 mg of efavirenz.
DOSAGE: For dosage and full prescribing
information, read accompanying package
insert.
Note to pharmacist: Do not cover
ALERT box with pharmacy label.

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

PRINCIPAL DISPLAY PANEL -- 600 mg Label
(click image for full-size original)
SUSTIVA efavirenz tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4668(NDC:0056-0510)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
efavirenz (efavirenz) efavirenz 600 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
hydroxypropyl cellulose
lactose monohydrate
magnesium stearate
cellulose, microcrystalline
sodium lauryl sulfate
carnauba wax
Product Characteristics
Color yellow (yellow) Score no score
Shape OVAL (capsule-shaped) Size 19mm
Flavor Imprint Code SUSTIVA;SUSTIVA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4668-0 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021360 10/11/2012
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel (54868-4668)

Revised: 01/2013 Physicians Total Care, Inc.

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