EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68180-287-06

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg

Bottle of 30 tablets

Rx only

Goa Label
(click image for full-size original)

NDC 68180-287-01

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg

Bottle of 100 tablets

Rx only

image 3
(click image for full-size original)
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine and tenofovir disoproxil fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-287
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EMTRICITABINE (EMTRICITABINE) EMTRICITABINE 200 mg
TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR ANHYDROUS) TENOFOVIR DISOPROXIL FUMARATE 300 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MANNITOL
SILICON DIOXIDE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score no score
Shape CAPSULE (Biconvex film-coated) Size 19mm
Flavor Imprint Code LU;Q31
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-287-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68180-287-06 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204131 06/23/2021
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 677600414 MANUFACTURE (68180-287), PACK (68180-287)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 650759348 MANUFACTURE (68180-287), PACK (68180-287)

Revised: 06/2021 Lupin Pharmaceuticals, Inc.

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