NDC Code(s) : 0006-5007-01
Packager : Merck Sharp & Dohme LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DELSTRIGOdoravirine, lamivudine, and tenofovir disoproxil fumarate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-5007
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
doravirine(UNII: 913P6LK81M)
(doravirine - UNII:913P6LK81M) 		doravirine100 mg
lamivudine(UNII: 2T8Q726O95)
(lamivudine - UNII:2T8Q726O95) 		lamivudine300 mg
tenofovir disoproxil fumarate(UNII: OTT9J7900I)
(tenofovir anhydrous - UNII:W4HFE001U5) 		tenofovir disoproxil fumarate300 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide(UNII: ETJ7Z6XBU4)
croscarmellose sodium(UNII: M28OL1HH48)
hypromellose acetate succinate 06081224 (3 MM2/S)(UNII: 6N003M473W)
magnesium stearate(UNII: 70097M6I30)
microcrystalline cellulose(UNII: OP1R32D61U)
sodium stearyl fumarate(UNII: 7CV7WJK4UI)
carnauba wax(UNII: R12CBM0EIZ)
hypromellose, unspecified(UNII: 3NXW29V3WO)
ferric oxide yellow(UNII: EX438O2MRT)
lactose monohydrate(UNII: EWQ57Q8I5X)
titanium dioxide(UNII: 15FIX9V2JP)
triacetin(UNII: XHX3C3X673)
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 22 mm
Flavor Imprint Code logo;776
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0006-5007-0130 in 1 BOTTLE Type 0: Not a Combination Product20/07/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210807 07/20/2018

LABELER - Merck Sharp & Dohme LLC(118446553)

PRINCIPAL DISPLAY PANEL

NDC 0006-5007-01

Delstrigo®
(doravirine, lamivudine, and
tenofovir disoproxil fumarate) tablets

100mg/300mg /300mg

Each tablet contains 100 mg doravirine, 300 mg
lamivudine, and 300 mg tenofovir disoproxil fumarate
(equivalent to 245 mg tenofovir disoproxil).

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

Rx only

30 Tablets

PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label