Amoxicillin and Clavulanate Potassium

Product NDC
70518-2325
11-digit product format
705182325
Labeler code
70518
Product ID
70518-2325_d84b3f15-b095-b51b-e053-2995a90a116c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065093
Marketing category
ANDA
Marketing start
2019-09-24
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2325-0EA - Each70518-23255c0a3055-b202-41d9-9c0c-f19f522bc57312023-01-09
70518-2325-1EA - Each70518-2325655a4e6d-3eb9-4165-acd2-da8b0f7d334412023-01-09
70518-2325-2EA - Each70518-2325b4506c9d-ba56-4536-b5ed-27a23ae78f2112023-01-09
70518-2325-3EA - Each70518-2325004a5184-b658-4f87-88be-95977c12fde112023-01-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2325-07051823250010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2325-0) 2019-09-240000-00-00NoNoCurrent
70518-2325-17051823250120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2325-1) 2021-09-240000-00-00NoNoCurrent
70518-2325-270518232502100 POUCH in 1 BOX (70518-2325-2) > 1 TABLET, FILM COATED in 1 POUCH (70518-2325-3) 100 pouch2022-02-170000-00-00NoNoCurrent