Amoxicillin and Clavulanate Potassium

Product NDC
68788-0047
11-digit product format
687880047
Labeler code
68788
Product ID
68788-0047_9888ea04-c7ba-4873-8be1-7f1d6939652f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA065191
Marketing category
ANDA
Marketing start
2011-03-31
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANIC ACID
Active strength
200 mg/5mL; mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-0047-168788004701100 mL in 1 BOTTLE (68788-0047-1) 100 ml2011-03-310000-00-00NoNoCurrent