Amoxicillin and Clavulanate Potassium

Product NDC
68788-8305
11-digit product format
687888305
Labeler code
68788
Product ID
68788-8305_4b5bcf3b-6f6e-420c-8bb8-2dc58aabb8a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065066
Marketing category
ANDA
Marketing start
2022-12-19
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
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
68788-8305-1ML - Milliliter68788-83055e145736-7834-4115-9a49-63b8d2d8d87e12023-02-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8305-168788830501100 mL in 1 BOTTLE (68788-8305-1) 100 ml2022-12-190000-00-00NoNoCurrent