Amoxicillin and Clavulanate Potassium

Product NDC
45865-927
11-digit product format
458650927
Labeler code
45865
Product ID
45865-927_9adcc2c9-5222-2582-e053-2995a90ab208
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA065098
Marketing category
ANDA
Marketing start
2004-08-13
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
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
ebb3e917-326a-9e18-0354-a19c9f63a2f3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-927-01Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-927AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20191230_9adcc244-a70a-8efb-e053-2a95a90af205.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN9adcc244-a70a-8efb-e053-2a95a90af2051
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD9adcc244-a70a-8efb-e053-2a95a90af2051
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY9adcc244-a70a-8efb-e053-2a95a90af2051
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY9adcc244-a70a-8efb-e053-2a95a90af2051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-927-014586509270175 mL in 1 BOTTLE (45865-927-01) 75 ml2018-12-120000-00-00NoNoCurrent