Amoxicillin and Clavulanate Potassium

Product NDC
45865-980
11-digit product format
458650980
Labeler code
45865
Product ID
45865-980_9af147ca-cb10-3194-e053-2a95a90aa0a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA203824
Marketing category
ANDA
Marketing start
2016-08-23
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
875 mg/1; mg/1
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
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
45865-980-20Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-980AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20191231_9af14455-3286-8f6e-e053-2a95a90a6034.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN9af14455-3286-8f6e-e053-2a95a90a60341
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD9af14455-3286-8f6e-e053-2a95a90a60341
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY9af14455-3286-8f6e-e053-2a95a90a60341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-980-204586509802020 TABLET in 1 BOTTLE (45865-980-20) 20 tablet2019-12-110000-00-00NoNoCurrent