Atovaquone

Product NDC
0121-1796
11-digit product format
001211796
Labeler code
0121
Product ID
0121-1796_0d67fa4c-b36a-4d81-8e7d-a661db92df22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
PAI Holdings, LLC
Application
ANDA210692
Marketing category
ANDA
Marketing start
2018-10-11
Marketing end
0000-00-00
Substance
ATOVAQUONE
Active strength
1500 mg/10mL
Pharmacologic classes
Antimalarial [EPC], Antiprotozoal [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1796-10ML - Milliliter0121-17966ada6e6c-f5f2-46d7-b9a8-a2350b7950b612022-02-07
0121-1796-20ML - Milliliter0121-17960527d583-c862-4c4d-bdfe-4238d2b56b0612022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1796ATOVAQUONE SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]11Legacy NDC20250109_ba4bea2e-aeec-084d-e053-2a95a90a04d4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-1796-20001211796202 TRAY in 1 CASE (0121-1796-20) > 10 PACKAGE in 1 TRAY > 10 mL in 1 PACKAGE (0121-1796-10) 2 tray2021-12-160000-00-00NoNoCurrent