Amoxicillin and Clavulanate Potassium

Product NDC
69452-336
11-digit product format
694520336
Labeler code
69452
Product ID
69452-336_3d370466-2b90-4d0b-9bf8-6297353d18ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA065064
Marketing category
ANDA
Marketing start
2022-08-01
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
69452-336-11EA - Each69452-33658633202-c153-46ec-87ba-9125ff85482112022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-336AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [BIONPHARMA INC.]5Legacy NDC20240514_80daca9e-1539-4f25-911f-b8868438ced8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69452-336-116945203361120 TABLET, FILM COATED in 1 BOTTLE (69452-336-11) 2022-08-010000-00-00NoNoCurrent