Amoxicillin and Clavulanate Potassium

Product NDC
50090-6997
11-digit product format
500906997
Labeler code
50090
Product ID
50090-6997_7e0dcbd4-5b61-45a7-afaa-7d97da1285f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091569
Marketing category
ANDA
Marketing start
2012-01-20
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
500; 125 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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6997-05009069970014 TABLET, FILM COATED in 1 BOTTLE (50090-6997-0) 2023-12-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amoxicillin and Clavulanate PotassiumA-S Medication Solutions2024-06-28Human Prescription Drug Label4