Amoxicillin and Clavulanate Potassium

Product NDC
43858-605
11-digit product format
438580605
Labeler code
43858
Product ID
43858-605_695710cf-342f-4ecd-822c-12b843ddb9b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Sandoz GmbH
Application
ANDA065066
Marketing category
ANDA
Marketing start
2015-10-21
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
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43858-605-4643858060546100 mL in 1 BOTTLE (43858-605-46) 100 ml2015-10-210000-00-00NoNoCurrent