FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
33261-989
11-digit product format
332610989
Labeler code
33261
Product ID
33261-989_603f002e-7b62-4777-be74-66e0ffffb894
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA201090
Marketing category
ANDA
Marketing start
2011-12-20
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
400 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
33261-989-012020-01-31C16284748780-19d75b9d0-1e52-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 and other antibacteria

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-989-01Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLE, PLASTICPOWDER, FOR SUSPENSION751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-989AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140321_9290fcb9-7991-44b6-9045-1ed3fdfe2b28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN9290fcb9-7991-44b6-9045-1ed3fdfe2b281
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD9290fcb9-7991-44b6-9045-1ed3fdfe2b281
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY9290fcb9-7991-44b6-9045-1ed3fdfe2b281
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY9290fcb9-7991-44b6-9045-1ed3fdfe2b281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
33261-989-013326109890175 mL in 1 BOTTLE, PLASTIC75 mlHistorical