Amoxicillin and Clavulanate Potassium

Product NDC
72789-083
11-digit product format
727890083
Labeler code
72789
Product ID
72789-083_dd9382b8-901f-4929-e053-2a95a90a75f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
NDA050720
Marketing category
NDA
Marketing start
2019-12-12
Marketing end
2022-06-01
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-083-03EA - Each72789-083e44d68a7-3fa5-4732-ad28-be222bc2509d12020-08-06
72789-083-04EA - Each72789-08310de5191-866d-454a-a776-33730ae8a66512020-08-06
72789-083-06EA - Each72789-083b92c4d05-c39f-4173-b1c0-2780fe2b494912020-09-14
72789-083-14EA - Each72789-083208b4911-99b1-481a-8554-b65e86a3021f12020-07-13
72789-083-20EA - Each72789-083fa269fab-d95a-4b7c-ba23-ecc64c6c933b12020-06-05
72789-083-28EA - Each72789-08366c454f9-9ba0-4039-a067-1fa30bc951f912020-07-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-083-03727890083033 TABLET in 1 BOTTLE, PLASTIC (72789-083-03) 3 tablet2020-06-162022-06-01NoNoCurrent
72789-083-04727890083044 TABLET in 1 BOTTLE, PLASTIC (72789-083-04) 4 tablet2020-07-080000-00-00NoNoCurrent
72789-083-06727890083066 TABLET in 1 BOTTLE, PLASTIC (72789-083-06) 6 tablet2020-07-150000-00-00NoNoCurrent
72789-083-147278900831414 TABLET in 1 BOTTLE, PLASTIC (72789-083-14) 14 tablet2020-05-192022-06-01NoNoCurrent
72789-083-207278900832020 TABLET in 1 BOTTLE, PLASTIC (72789-083-20) 20 tablet2020-05-112022-06-01NoNoCurrent
72789-083-287278900832828 TABLET in 1 BOTTLE, PLASTIC (72789-083-28) 28 tablet2020-05-262022-06-01NoNoCurrent