Amoxicillin and Clavulanate Potassium

Product NDC
42254-282
11-digit product format
422540282
Labeler code
42254
Product ID
42254-282_f0c660da-4198-4d04-87e9-5d6a7b6f75cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA050575
Marketing category
NDA
Marketing start
1990-10-22
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
E
Listing certified through
2017-12-31
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
42254-282-002019-09-24C16284748780-19350213a-3d16-c013-e053-90daa90a1393Amoxicillin and Clavulanate Potassium Powder for Oral Suspension and Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-282-00Amoxicillin and Clavulanate Potassium100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-282-00ML - Milliliter42254-282ad66ee05-cf39-411e-b550-fd669aae673f12013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-282AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20121201_f0c660da-4198-4d04-87e9-5d6a7b6f75cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNf0c660da-4198-4d04-87e9-5d6a7b6f75cf1
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDf0c660da-4198-4d04-87e9-5d6a7b6f75cf1
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYf0c660da-4198-4d04-87e9-5d6a7b6f75cf1
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYf0c660da-4198-4d04-87e9-5d6a7b6f75cf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42254-282-0042254028200100 mL in 1 BOTTLE100 mlHistorical