Amoxicillin and Clavulanate Potassium

Product NDC
68788-7127
11-digit product format
687887127
Labeler code
68788
Product ID
68788-7127_896a91c9-286a-4279-b377-879e2109bccd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065162
Marketing category
ANDA
Marketing start
2018-03-23
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
600 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
68788-7127-168788712701125 mL in 1 BOTTLE (68788-7127-1) 125 ml2018-03-230000-00-00NoNoCurrent
68788-7127-76878871270775 mL in 1 BOTTLE (68788-7127-7) 75 ml2018-03-230000-00-00NoNoCurrent