Prescription Drug Information: Atovaquone (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

Atovaquone Oral Suspension, USP is a bright yellow, tutti frutti flavored, oral suspension containing 750 mg of atovaquone USP in 5 mL. It is supplied as follows:

NDC 68462-421-21 Bottle of 210 mL with child-resistant cap
NDC 68462-421-69 Carton of 42 sachets (5 mL unit-dose)

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze.

17 PATIENT COUNSELING INFORMATION

Administration Instructions

Instruct patients to:

Ensure the prescribed dose of atovaquone oral suspension is taken as directed.
Take their daily doses of atovaquone oral suspension with food, as food will significantly improve the absorption of the drug.
Shake atovaquone oral suspension gently before use each time.

Manufactured by:

Glenmark Pharmaceuticals Limited

Village: Kishanpura,

Baddi Nalagarh Road,

District: Solan,

Himachal Pradesh – 173205, India

Manufactured for:

logo

Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

Questions? 1 (888) 721-7115

www.glenmarkpharma-us.com

September 2019

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 68462-421-21

Atovaquone Oral Suspension, USP

750 mg/5 ml

Bottle Label

bottle-label
(click image for full-size original)
ATOVAQUONE
atovaquone suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-421
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOVAQUONE (ATOVAQUONE) ATOVAQUONE 750 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
WATER
POLOXAMER 188
HYPROMELLOSE 2910 (3 MPA.S)
BENZYL ALCOHOL
XANTHAN GUM
SACCHARIN SODIUM
CITRIC ACID MONOHYDRATE
TRISODIUM CITRATE DIHYDRATE
Product Characteristics
Color YELLOW (bright yellow) Score
Shape Size
Flavor TUTTI FRUTTI (tutti frutti) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-421-21 210 mL in 1 BOTTLE None
2 NDC:68462-421-69 42 POUCH in 1 CARTON contains a POUCH
2 5 mL in 1 POUCH This package is contained within the CARTON (68462-421-69)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209685 12/31/2017
Labeler — Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 676115028 MANUFACTURE (68462-421), ANALYSIS (68462-421)

Revised: 09/2019 Glenmark Pharmaceuticals Inc., USA

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