Amoxicillin and Clavulanate Potassium

Product NDC
71205-651
11-digit product format
712050651
Labeler code
71205
Product ID
71205-651_f636413f-82e5-446f-94cc-b4841bdedb33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065063
Marketing category
ANDA
Marketing start
2020-05-01
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
875; 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
71205-651-107120506511010 TABLET, FILM COATED in 1 BOTTLE (71205-651-10) 2022-04-21NoNoHistorical
71205-651-207120506512020 TABLET, FILM COATED in 1 BOTTLE (71205-651-20) 2022-04-21NoNoHistorical
71205-651-307120506513030 TABLET, FILM COATED in 1 BOTTLE (71205-651-30) 2022-04-21NoNoHistorical
71205-651-607120506516060 TABLET, FILM COATED in 1 BOTTLE (71205-651-60) 2022-04-21NoNoHistorical
71205-651-907120506519090 TABLET, FILM COATED in 1 BOTTLE (71205-651-90) 2022-04-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amoxicillin and Clavulanate PotassiumProficient Rx LP2022-04-01HUMAN PRESCRIPTION DRUG LABEL1