FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
50436-5166
11-digit product format
504365166
Labeler code
50436
Product ID
50436-5166_511abdb0-d6aa-488d-a421-857afa9498d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA065162
Marketing category
ANDA
Marketing start
2004-09-23
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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-5166-12021-01-29C16284748780-1ba0f9c33-0d2a-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use USP safely and effectively. See full prescribing information for . AMOXICILLIN and CLAVULANATE POTASSIUM for oral suspension USP powder for oral suspension 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 antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, should be used only to trea

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-5166-1Amoxicillin and Clavulanate Potassium125 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-5166AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [UNIT DOSE SERVICES]3Legacy NDC, 1 package rows20160421_6c54661e-e530-424d-8d5d-4690c4df0b41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN6c54661e-e530-424d-8d5d-4690c4df0b413
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD6c54661e-e530-424d-8d5d-4690c4df0b413
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY6c54661e-e530-424d-8d5d-4690c4df0b413
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY6c54661e-e530-424d-8d5d-4690c4df0b413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50436-5166-150436516601125 mL in 1 BOTTLE125 mlHistorical