FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
50436-1001
11-digit product format
504361001
Labeler code
50436
Product ID
50436-1001_be0b5462-d651-4ea6-bd63-1bb0e5f0ae8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA065093
Marketing category
ANDA
Marketing start
2002-11-21
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
ebb3e917-326a-9e18-0354-a19c9f63a2f3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-1001-12021-01-29C16284748780-1ba0f9c33-4329-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amoxicillin and clavulanate potassium safely and effectively. See full prescribing information for amoxicillin and clavulanate potassium. AMOXICILLIN and CLAVULANATE Potassium Tablets, USP and For Oral Suspension USP, for Oral Use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate pot

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-1001-1Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-1001AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [UNIT DOSE SERVICES]6Legacy NDC, 1 package rows20190209_5aaa128c-04f5-4fc3-9a5c-7c417572d308.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN5aaa128c-04f5-4fc3-9a5c-7c417572d3086
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN5aaa128c-04f5-4fc3-9a5c-7c417572d3086
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD5aaa128c-04f5-4fc3-9a5c-7c417572d3086
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD5aaa128c-04f5-4fc3-9a5c-7c417572d3086
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY5aaa128c-04f5-4fc3-9a5c-7c417572d3086
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY5aaa128c-04f5-4fc3-9a5c-7c417572d3086

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-1001-15043610010120 in 1 BOTTLEHistorical