Amoxicillin and Clavulanate Potassium

Product NDC
50090-4415
11-digit product format
500904415
Labeler code
50090
Product ID
50090-4415_2a23a81e-cf99-4c47-867b-fe6e5b613505
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091568
Marketing category
ANDA
Marketing start
2012-01-20
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
2021-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
804826J2HUAMOXICILLIN61336-70-7AMOXICILLIN
Q42OMW3AT8CLAVULANATE POTASSIUM61177-45-5CLAVULANATE POTASSIUM

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4415-05009044150020 TABLET, FILM COATED in 1 BOTTLE (50090-4415-0) 2019-07-160000-00-00NoNoCurrent
50090-4415-15009044150120 TABLET, FILM COATED in 1 BOTTLE (50090-4415-1) 2019-07-160000-00-00NoNoCurrent