Amoxicillin and Clavulanate Potassium

Product NDC
70518-3523
11-digit product format
705183523
Labeler code
70518
Product ID
70518-3523_e8a64fa3-66d9-18b8-e053-2995a90ae4f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065064
Marketing category
ANDA
Marketing start
2022-09-14
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
500 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3523-07051835230030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3523-0) 2022-09-140000-00-00NoNoCurrent