Amoxicillin and Clavulanate Potassium

Product NDC
68788-0598
11-digit product format
687880598
Labeler code
68788
Product ID
68788-0598_9888ea04-c7ba-4873-8be1-7f1d6939652f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA065191
Marketing category
ANDA
Marketing start
2011-03-31
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANIC ACID
Active strength
400 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
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
68788-0598-1ML - Milliliter68788-05980425d28a-470b-423f-909d-72bf8a19f2bc12020-05-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-0598-168788059801100 mL in 1 BOTTLE (68788-0598-1) 100 ml2011-03-310000-00-00NoNoCurrent