Amoxicillin and Clavulanate Potassium

Product NDC
82804-201
11-digit product format
828040201
Labeler code
82804
Product ID
82804-201_c8030539-314f-437d-abe7-415d6e58add7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
82804-201-208280402012020 TABLET, FILM COATED in 1 BOTTLE (82804-201-20) 2025-03-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amoxicillin and Clavulanate PotassiumProficient Rx LP2025-03-01HUMAN PRESCRIPTION DRUG LABEL1