Amoxicillin and Clavulanate Potassium

Product NDC
33261-600
11-digit product format
332610600
Labeler code
33261
Product ID
33261-600_7f5fefc0-1979-45a2-966c-616ca2ccfa7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
NDA050755
Marketing category
NDA
Marketing start
2001-06-22
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
33261-600-012020-01-31C16284748780-19d75b9d1-2a81-f424-e053-dadaa90a57ceAmoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL Powder for Oral Suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-600-01Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLE, PLASTICPOWDER, FOR SUSPENSION752

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-600AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 1 package rows20140325_f5cdf1cd-bdcd-413a-b2ba-5d99050b2dc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSNf5cdf1cd-bdcd-413a-b2ba-5d99050b2dc62
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCDf5cdf1cd-bdcd-413a-b2ba-5d99050b2dc62
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSYf5cdf1cd-bdcd-413a-b2ba-5d99050b2dc62
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSYf5cdf1cd-bdcd-413a-b2ba-5d99050b2dc62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
33261-600-013326106000175 mL in 1 BOTTLE, PLASTIC75 mlHistorical