Amoxicillin and Clavulanate Potassium

Product NDC
72789-459
11-digit product format
727890459
Labeler code
72789
Product ID
72789-459_4db262cf-c013-66d1-e063-6294a90a98fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA091568
Marketing category
ANDA
Marketing start
2012-01-20
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
2027-12-31
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
72789-459-147278904591414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-459-14) 2024-12-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.2026-03-23HUMAN PRESCRIPTION DRUG LABEL24