Amoxicillin and Clavulanate Potassium

Product NDC
71335-2999
11-digit product format
713352999
Labeler code
71335
Product ID
71335-2999_6e01dd3f-c563-4091-a07f-52bbb6d51b0a
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
71335-2999-17133529990120 TABLET, FILM COATED in 1 BOTTLE (71335-2999-1) 2025-11-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amoxicillin and Clavulanate PotassiumBryant Ranch Prepack2025-11-05HUMAN PRESCRIPTION DRUG LABEL100