Symtuza (Page 10 of 10)

PRINCIPAL DISPLAY PANEL — 30 Tablet Bottle Label

NDC 59676-800-30

Symtuza™
(darunavir, cobicistat,
emtricitabine, and tenofovir
alafenamide) tablets

800 mg / 150 mg /
200 mg / 10 mg

Each tablet contains darunavir
ethanolate equivalent to 800 mg
of darunavir, 150 mg of cobicistat,
200 mg of emtricitabine, and
tenofovir alafenamide fumarate
equivalent to 10 mg of tenofovir
alafenamide.

Rx only 30 Tablets

PRINCIPAL DISPLAY PANEL -- 30 Tablet Bottle Label
(click image for full-size original)
SYMTUZA darunavir, cobicistat, emtricitabine, and tenofovir alafenamide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-800
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Darunavir (Darunavir) Darunavir 800 mg
Cobicistat (Cobicistat) Cobicistat 150 mg
Emtricitabine (Emtricitabine) Emtricitabine 200 mg
Tenofovir alafenamide (TENOFOVIR ANHYDROUS) TENOFOVIR ALAFENAMIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
croscarmellose sodium
magnesium stearate
microcrystalline cellulose
POLYETHYLENE GLYCOL, UNSPECIFIED
talc
titanium dioxide
FERRIC OXIDE YELLOW
Product Characteristics
Color BROWN (yellow to yellowish-brown) Score no score
Shape OVAL (capsule-shaped, film-coated tablet) Size 22mm
Flavor Imprint Code 8121;JG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-800-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:59676-800-99 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210455 07/17/2018
Labeler — Janssen Products LP (804684207)
Establishment
Name Address ID/FEI Operations
Janssen Cilag SpA 542797928 PACK (59676-800), MANUFACTURE (59676-800)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceuticals, Inc. 868441320 ANALYSIS (59676-800)
Establishment
Name Address ID/FEI Operations
Janssen Ortho LLC 805887986 PACK (59676-800)
Establishment
Name Address ID/FEI Operations
Gilead Alberta ULC 207452996 API MANUFACTURE (59676-800)
Establishment
Name Address ID/FEI Operations
Esteve Quimica, SA 633485529 API MANUFACTURE (59676-800)
Establishment
Name Address ID/FEI Operations
Yuhan Chemical, Inc. 687831958 API MANUFACTURE (59676-800)
Establishment
Name Address ID/FEI Operations
Evonik Operations GmbH 343170605 API MANUFACTURE (59676-800)
Establishment
Name Address ID/FEI Operations
Union Quimico Farmaceutica SA (Uquifa) 460940868 API MANUFACTURE (59676-800)
Establishment
Name Address ID/FEI Operations
AMPAC Fine Chemicals 073903937 API MANUFACTURE (59676-800)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutica NV 400345889 MANUFACTURE (59676-800)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutical Sciences Unlimited Company 985639841 MANUFACTURE (59676-800), ANALYSIS (59676-800)
Establishment
Name Address ID/FEI Operations
Patheon, Inc. 240769596 MANUFACTURE (59676-800), ANALYSIS (59676-800)

Revised: 08/2021 Janssen Products LP

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