Amoxicillin and Clavulanate Potassium

Product NDC
69043-036
11-digit product format
690430036
Labeler code
69043
Product ID
69043-036_214a4c12-5617-4397-ac7a-00f370d3fdc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Cronus Pharma LLC
Application
ANDA209371
Marketing category
ANDA
Marketing start
2019-04-19
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
250 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
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69043-036-756904300367575 mL in 1 BOTTLE (69043-036-75) 75 ml2019-04-190000-00-00NoNoCurrent