Amoxicillin and Clavulanate Potassium

Product NDC
68071-3860
11-digit product format
680713860
Labeler code
68071
Product ID
68071-3860_36d60283-482e-9449-e063-6394a90ae216
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare 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
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
68071-3860-26807138600220 TABLET, FILM COATED in 1 BOTTLE (68071-3860-2) 2025-06-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals, Inc.2025-06-05HUMAN PRESCRIPTION DRUG LABEL1