Atovaquone

Product NDC
0121-0888
11-digit product format
001210888
Labeler code
0121
Product ID
0121-0888_ed380892-72da-aee8-e053-2995a90a8d1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA209105
Marketing category
ANDA
Marketing start
2018-11-07
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
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
0121-0888-05ML - Milliliter0121-08889d435e81-72be-49f8-ad74-5ca0de17dc6c12020-07-13
0121-0888-18ML - Milliliter0121-08882d03ea70-1fad-4f6a-90c7-565fb474f28f12020-07-13
0121-0888-42ML - Milliliter0121-0888625cebc3-5579-4d30-a872-276be4b3685d12020-07-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0888-18001210888183 TRAY in 1 CASE (0121-0888-18) > 6 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0888-05) 3 tray2020-04-300000-00-00NoNoCurrent
0121-0888-42001210888427 TRAY in 1 CASE (0121-0888-42) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0888-05) 7 tray2020-04-300000-00-00NoNoCurrent