Amoxicillin and Clavulanate Potassium

Product NDC
80425-0217
11-digit product format
804250217
Labeler code
80425
Product ID
80425-0217_f1d6f7ac-c13d-870d-e053-2a95a90ae2ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA065093
Marketing category
ANDA
Marketing start
2023-01-04
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
875 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
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0217-1EA - Each80425-02170a7c997d-de73-47c6-83fd-70c7995d5b1112023-03-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0217-18042502170120 TABLET, FILM COATED in 1 BOTTLE (80425-0217-1) 2023-01-040000-00-00NoNoCurrent