NDC Code(s) : 61958-2501-1, 61958-2501-2, 61958-2501-3, 61958-2505-1
Packager : Gilead Sciences, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61958-2501
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BICTEGRAVIR SODIUM(UNII: 4L5MP1Y7W7)
(BICTEGRAVIR - UNII:8GB79LOJ07) 		BICTEGRAVIR50 mg
EMTRICITABINE(UNII: G70B4ETF4S)
(EMTRICITABINE - UNII:G70B4ETF4S) 		EMTRICITABINE200 mg
TENOFOVIR ALAFENAMIDE FUMARATE(UNII: FWF6Q91TZO)
(TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) 		TENOFOVIR ANHYDROUS25 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
WATER(UNII: 059QF0KO0R)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TALC(UNII: 7SEV7J4R1U)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color brown (purplish-brown) Score no score
Shape OVAL (capsule-shaped) Size 15 mm
Flavor Imprint Code GSI;9883
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61958-2501-130 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/07/2018
2NDC:61958-2501-27 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/07/2018
3NDC:61958-2501-330 in 1 BLISTER PACK Type 0: Not a Combination Product24/08/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210251 02/07/2018
Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61958-2505
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BICTEGRAVIR SODIUM(UNII: 4L5MP1Y7W7)
(BICTEGRAVIR - UNII:8GB79LOJ07) 		BICTEGRAVIR30 mg
EMTRICITABINE(UNII: G70B4ETF4S)
(EMTRICITABINE - UNII:G70B4ETF4S) 		EMTRICITABINE120 mg
TENOFOVIR ALAFENAMIDE FUMARATE(UNII: FWF6Q91TZO)
(TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) 		TENOFOVIR ANHYDROUS15 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
WATER(UNII: 059QF0KO0R)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TALC(UNII: 7SEV7J4R1U)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK (pink) Score no score
Shape OVAL (capsule-shaped) Size 14 mm
Flavor Imprint Code GSI;B
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61958-2505-130 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/07/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210251 10/07/2021

LABELER - Gilead Sciences, Inc.(185049848)

PRINCIPAL DISPLAY PANEL

NDC 61958-2501-1

30 tablets

Biktarvy ®

(bictegravir, emtricitabine, and

tenofovir alafenamide) tablets

50 mg /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 Biktarvy

biktarvy-04.jpg

PRINCIPAL DISPLAY PANEL

NDC 61958-2505-1
30 tablets

Biktarvy®
(bictegravir, emtricitabine,
and tenofovir alafenamide)
tablets
30 mg / 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 Biktarvy

PRINCIPAL DISPLAY PANEL - 30 mg/120 mg/15 mg Tablet Bottle Label