Amoxicillin and Clavulanate Potassium

Product NDC
68788-8306
11-digit product format
687888306
Labeler code
68788
Product ID
68788-8306_e8e7db14-6abd-4a5f-a3a9-74dc3f733262
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA201090
Marketing category
ANDA
Marketing start
2022-12-20
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
200; 28.5 mg/5mL; mg/5mL
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8306-168788830601100 mL in 1 BOTTLE (68788-8306-1) 100 ml2022-12-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.2026-02-27HUMAN PRESCRIPTION DRUG LABEL5