Amoxicillin and Clavulanate Potassium

Product NDC
68788-7958
11-digit product format
687887958
Labeler code
68788
Product ID
68788-7958_e6eb4cfa-12a1-4888-b0ed-fc2650843cce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065063
Marketing category
ANDA
Marketing start
2021-07-19
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
875 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
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7958-2EA - Each68788-79581b0d5760-c81b-4099-b8e5-a08007acf9df12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7958AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]4Legacy NDC20240209_5b4cf295-e859-4537-91be-5f58443851cb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7958-26878879580220 TABLET, FILM COATED in 1 BOTTLE (68788-7958-2) 2021-07-190000-00-00NoNoCurrent