DESCOVY (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 200 mg/25 mg Tablet Bottle Label

NDC 61958- 2002 -1
30 tablets

Descovy ®
(emtricitabine and tenofovir
alafenamide) Tablets

200 mg/25 mg

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

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

//medlibrary.org/lib/images-rx/descovy/descovy-03-300x134.jpg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 Tablet Blister Pack

NDC 61958-2002-2
30 tablet blister pack

Descovy®
(emtricitabine and
tenofovir alafenamide) tablets
200 mg / 25 mg

Rx only

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

ALERT: Find out about medicines thatshould NOT be taken with Descovy

//medlibrary.org/lib/images-rx/descovy/descovy-04-300x182.jpg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 120 mg/15 mg Tablet Bottle Label

NDC 61958-2005-1
30 tablets

Descovy®
(emtricitabine and
tenofovir alafenamide)
tablets

120 mg/15 mg

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

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

PRINCIPAL DISPLAY PANEL -- 120 mg/15 mg Tablet Bottle Label
(click image for full-size original)
DESCOVY emtricitabine and tenofovir alafenamide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61958-2002
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EMTRICITABINE (EMTRICITABINE) EMTRICITABINE 200 mg
TENOFOVIR ALAFENAMIDE FUMARATE (TENOFOVIR ANHYDROUS) TENOFOVIR ALAFENAMIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
WATER
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
TALC
FD&C BLUE NO. 2
Product Characteristics
Color blue Score no score
Shape OVAL (rectangular-shaped) Size 13mm
Flavor Imprint Code GSI;255
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61958-2002-1 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:61958-2002-2 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208215 04/04/2016
DESCOVY emtricitabine and tenofovir alafenamide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61958-2005
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EMTRICITABINE (EMTRICITABINE) EMTRICITABINE 120 mg
TENOFOVIR ALAFENAMIDE FUMARATE (TENOFOVIR ANHYDROUS) TENOFOVIR ALAFENAMIDE 15 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
WATER
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
TALC
Product Characteristics
Color WHITE Score no score
Shape ROUND (round-shaped) Size 8mm
Flavor Imprint Code GSI;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61958-2005-1 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208215 01/07/2022
Labeler — Gilead Sciences, Inc. (185049848)

Revised: 01/2022 Gilead Sciences, Inc.

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