Amoxicillin and Clavulanate Potassium

Product NDC
68788-9424
11-digit product format
687889424
Labeler code
68788
Product ID
68788-9424_dfbace3a-7957-4714-a4bb-3d0e7d783bda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA065098
Marketing category
ANDA
Marketing start
2014-11-13
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
400 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
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
68788-9424-168788942401100 mL in 1 BOTTLE (68788-9424-1) 100 ml2014-11-130000-00-00NoNoCurrent