Amoxicillin and Clavulanate Potassium

Product NDC
72162-2210
11-digit product format
721622210
Labeler code
72162
Product ID
72162-2210_cef7f4b1-d750-4f09-aa7a-25afaf2020d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA065064
Marketing category
ANDA
Marketing start
2002-03-15
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
72162-2210-27216222100220 TABLET, FILM COATED in 1 BOTTLE (72162-2210-2) 2002-03-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amoxicillin and Clavulanate PotassiumBryant Ranch Prepack2024-05-29HUMAN PRESCRIPTION DRUG LABEL101