Amoxicillin and Clavulanate Potassium

Product NDC
68788-7965
11-digit product format
687887965
Labeler code
68788
Product ID
68788-7965_bf8c0f7a-9c00-4c90-a6fe-5edfcb133e02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065064
Marketing category
ANDA
Marketing start
2021-07-20
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7965-2EA - Each68788-79651048c5cd-ec66-411f-82db-8ef85f17574312021-10-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7965-26878879650220 TABLET, FILM COATED in 1 BOTTLE (68788-7965-2) 2021-07-200000-00-00NoNoCurrent