Atovaquone

Product NDC
0904-7064
11-digit product format
009047064
Labeler code
0904
Product ID
0904-7064_9b34e195-4e9c-4bed-8586-bf68c81873e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA210692
Marketing category
ANDA
Marketing start
2018-10-11
Marketing end
0000-00-00
Substance
ATOVAQUONE
Active strength
750 mg/5mL
Pharmacologic classes
Antimalarial [EPC],Antiprotozoal [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7064-250090470642518 CUP in 1 CARTON (0904-7064-25) > 5 mL in 1 CUP (0904-7064-41) 18 cup2018-10-110000-00-00NoNoCurrent
0904-7064-530090470645342 CUP in 1 CASE (0904-7064-53) > 5 mL in 1 CUP (0904-7064-41) 42 cup2018-10-110000-00-00NoNoCurrent