Emtricitabine and Tenofovir Disoproxil Fumarate: Package Insert and Label Information (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL — 30 Tablet Bottle Label

NDC 51407-112-30

Emtricitabine and Tenofovir

Disoproxil

Fumarate Tablets

200 mg/300 mg

30 tablets

Rx only

DISPENSER: Each time Emtricitabine and Tenofovir Disoproxil Fumarate Tablet is dispensed

give the patient the attached Medication Guide.

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EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine and tenofovir disoproxil fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-112(NDC:42543-719)
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
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code TE
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-112-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091055 01/13/2021
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 relabel (51407-112), repack (51407-112)

Revised: 04/2021 Golden State Medical Supply, Inc.

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