DOLUTEGRAVIR tablet, for suspension

Dolutegravir by

Drug Labeling and Warnings

Dolutegravir by is a Prescription medication manufactured, distributed, or labeled by Mylan Laboratories Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL – 10 mg

INGREDIENTS AND APPEARANCE

DOLUTEGRAVIR 
dolutegravir tablet, for suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 65015-353
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOLUTEGRAVIR SODIUM (UNII: 1Q1V9V5WYQ) (DOLUTEGRAVIR - UNII:DKO1W9H7M1)	DOLUTEGRAVIR	10 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM SULFATE DIHYDRATE (UNII: 4846Q921YM)
CROSPOVIDONE (UNII: 2S7830E561)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	PINK	Score	2 pieces
Shape	OVAL	Size	12mm
Flavor	STRAWBERRY (strawberry cream)	Imprint Code	D;T;M
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65015-353-14	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2020
2	NDC: 65015-353-17	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2020
3	NDC: 65015-353-18	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		11/19/2020

Labeler - Mylan Laboratories Limited (650547156)