Amoxicillin and Clavulanate Potassium

Product NDC
68788-9319
11-digit product format
687889319
Labeler code
68788
Product ID
68788-9319_bd47cf8e-250e-411c-9758-df17a4ae4b00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA065093
Marketing category
ANDA
Marketing start
2015-04-13
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
875 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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-9319-26878893190220 TABLET, FILM COATED in 1 BOTTLE (68788-9319-2) 2015-04-130000-00-00NoNoCurrent
68788-9319-8687889319088 TABLET, FILM COATED in 1 BOTTLE (68788-9319-8) 2015-04-130000-00-00NoNoCurrent