FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
53217-359
11-digit product format
532170359
Labeler code
53217
Product ID
53217-359_4854f461-fb86-4e3e-9c8a-63cdf0869acd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
SUSPENSION
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA065358
Marketing category
ANDA
Marketing start
2018-01-11
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
600 mg/5mL; mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
53217-359-012020-01-31C16284748780-19d75b9d0-bb06-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use amoxicillin and clavulanate potassium for oral suspension, USP safely and effectively. See full prescribing information for amoxicillin and clavulanate potassium for oral suspension, USP. AMOXICILLIN and CLAVULANATE potassium for oral suspension, USP Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium for Oral Suspension, USP and other antibac

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-359-01Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLE, DISPENSINGSUSPENSION751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-359AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180821_9f18d271-7cd8-4a4e-8087-6f11eddf0107.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN9f18d271-7cd8-4a4e-8087-6f11eddf01071
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD9f18d271-7cd8-4a4e-8087-6f11eddf01071
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY9f18d271-7cd8-4a4e-8087-6f11eddf01071
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY9f18d271-7cd8-4a4e-8087-6f11eddf01071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53217-359-015321703590175 mL in 1 BOTTLE, DISPENSING75 mlHistorical