AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC
68788-8307
11-digit product format
687888307
Labeler code
68788
Product ID
68788-8307_23c2896b-d08f-4948-ac77-e15df706eeac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
NDA050720
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-12-20
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
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 formatDescriptionMarketing startSampleExclude flagStatus
68788-8307-26878883070220 TABLET, COATED in 1 BOTTLE (68788-8307-2) 2022-12-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.2026-03-03HUMAN PRESCRIPTION DRUG LABEL4