AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC
72162-2435
11-digit product format
721622435
Labeler code
72162
Product ID
72162-2435_ef7f8e15-fbf4-488d-9372-df0239a505df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205707
Marketing category
ANDA
Marketing start
2017-03-01
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
250; 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
72162-2435-37216224350330 TABLET, FILM COATED in 1 BOTTLE (72162-2435-3) 2024-12-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepack2024-12-16HUMAN PRESCRIPTION DRUG LABEL100