Amoxicillin and Clavulanate Potassium

Product NDC
68788-8308
11-digit product format
687888308
Labeler code
68788
Product ID
68788-8308_2e65e24e-dc46-4884-847a-adf03a4f2e34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065101
Marketing category
ANDA
Marketing start
2022-12-20
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
68788-8308-2EA - Each68788-83085fd5441f-67b1-4024-a1f4-a9b1929c9e2712023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8308AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]5Legacy NDC20250126_2e65e24e-dc46-4884-847a-adf03a4f2e34.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8308-26878883080220 TABLET, FILM COATED in 1 BOTTLE (68788-8308-2) 2022-12-200000-00-00NoNoCurrent