Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate (Page 12 of 12)

PRINCIPAL DISPLAY PANEL — Container Label (30′s count)

NDC 42385-929 -30

Efavirenz, Lamivudine and

Tenofovir Disoproxil

Fumarate Tablets

400 mg/300 mg/300 mg

Note to Pharmacist:Do not cover

ALERT box with pharmacy label.

ALERT: Find out about medicines that

should NOT be taken with

Efavirenz, Lamivudine and Tenofovir

Disoproxil Fumarate Tablets.

30 Tablets Rx Only

LAURUS Labs

PRINCIPAL DISPLAY PANEL -- Container Label (30's count)
(click image for full-size original)

EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE efavirenz, lamivudine and tenofovir disoproxil fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42385-929
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EFAVIRENZ (EFAVIRENZ) EFAVIRENZ 400 mg
LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 300 mg
TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR ANHYDROUS) TENOFOVIR DISOPROXIL FUMARATE 300 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off-white) Score no score
Shape OVAL (biconvex) Size 21mm
Flavor Imprint Code L40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42385-929-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:42385-929-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:42385-929-18 180 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:42385-929-31 30 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:42385-929-91 90 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:42385-929-82 180 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213038 05/14/2020
Labeler — Laurus Labs Limited (915075687)
Establishment
Name Address ID/FEI Operations
Laurus Labs Limited (VSP2) 650885309 ANALYSIS (42385-929), MANUFACTURE (42385-929)

Revised: 05/2020 Laurus Labs Limited

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