NDC Code(s) : 70748-299-01
Packager : Lupin Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ATOVAQUONE ATOVAQUONE SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70748-299
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOVAQUONE(UNII: Y883P1Z2LT)
(ATOVAQUONE - UNII:Y883P1Z2LT) 		ATOVAQUONE750 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL(UNII: LKG8494WBH)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
POLOXAMER 188(UNII: LQA7B6G8JG)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
WATER(UNII: 059QF0KO0R)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color YELLOW Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70748-299-011 in 1 CARTON 06/01/2021
1210 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210692 06/01/2021

LABELER - Lupin Pharmaceuticals, Inc.(089153071)

REGISTRANT - Hetero Labs Limited Unit-III(676162024)

Establishment
Name Address ID/FEI Business Operations
Hetero Labs Limited Unit-III 676162024 MANUFACTURE(70748-299), PACK(70748-299)

PRINCIPAL DISPLAY PANEL

ATOVAQUONE ORAL SUSPENSION USP

Rx Only

210 mL

NDC 70748-299-01

750 mg/5 mL

Each 5 mL (1 teaspoonful) contains 750 mg of atovaquone USP.

SHAKE GENTLY BEFORE USING .

See accompanying prescribing information for Dosage and Administration

Store at 15 ºC to 25ºC (59 ºF to 77ºF)

DO NOT FREEZE. Dispense in a tight container as defined in USP. 

container-750mg/5mLcontainer-750mg/5mL