Amoxicillin and Clavulanate Potassium

Product NDC
50090-4413
11-digit product format
500904413
Labeler code
50090
Product ID
50090-4413_048fe5ef-29fa-49ac-a63e-00d2b1a7aa1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-4413-05009044130048 BOTTLE in 1 CASE (50090-4413-0) / 20 TABLET, FILM COATED in 1 BOTTLE48 bottle2019-07-16NoNoHistorical
50090-4413-15009044130124 BOTTLE in 1 CASE (50090-4413-1) / 20 TABLET, FILM COATED in 1 BOTTLE24 bottle2024-02-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amoxicillin and Clavulanate PotassiumA-S Medication Solutions2024-05-16Human Prescription Drug Label9