Amoxicillin and Clavulanate Potassium

Product NDC
68071-2630
11-digit product format
680712630
Labeler code
68071
Product ID
68071-2630_2a083b1e-0baa-b987-e063-6294a90a22c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065064
Marketing category
ANDA
Marketing start
2002-03-15
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
500; 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
68071-2630-26807126300220 TABLET, FILM COATED in 1 BOTTLE (68071-2630-2) 2022-02-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.2024-12-24HUMAN PRESCRIPTION DRUG LABEL2