Amoxicillin and Clavulanate Potassium

Product NDC
68788-8271
11-digit product format
687888271
Labeler code
68788
Product ID
68788-8271_c311e743-d41b-480a-a1d6-50a157a4578a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065096
Marketing category
ANDA
Marketing start
2022-10-13
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
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
68788-8271-2EA - Each68788-827162ccec27-ed32-4962-a6e0-ad0b7990521f12022-11-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8271-26878882710220 TABLET, FILM COATED in 1 BOTTLE (68788-8271-2) 2022-10-130000-00-00NoNoCurrent