Amoxicillin and Clavulanate Potassium

Product NDC
43858-607
11-digit product format
438580607
Labeler code
43858
Product ID
43858-607_695710cf-342f-4ecd-822c-12b843ddb9b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz GmbH
Application
ANDA065189
Marketing category
ANDA
Marketing start
2015-10-21
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
250 mg/1; mg/1
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43858-607-314385806073130 TABLET, FILM COATED in 1 BOTTLE (43858-607-31) 2015-10-210000-00-00NoNoCurrent