Amoxicillin and Clavulanate Potassium

Product NDC
68071-4360
11-digit product format
680714360
Labeler code
68071
Product ID
68071-4360_bb7ba4c6-0c62-286e-e053-2995a90ae33c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065162
Marketing category
ANDA
Marketing start
2004-09-23
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
600 mg/5mL; mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4360-568071436005125 mL in 1 BOTTLE (68071-4360-5) 125 ml2018-03-270000-00-00NoNoCurrent