FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
53002-3716
11-digit product format
530023716
Labeler code
53002
Product ID
53002-3716_c65de933-1491-4d39-931a-35aa827c6336
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA201091
Marketing category
ANDA
Marketing start
2011-12-20
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
2022-12-31
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
53002-3716-12025-01-30C16284748780-1f386c649-f82b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION. AMOXICILLIN and CLAVULANATE potassium for oral suspension, for oral use Initial U.S. Approval: 2001
53002-3716-22025-01-30C16284748780-1f386c649-f82b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION. AMOXICILLIN and CLAVULANATE potassium for oral suspension, for oral use Initial U.S. Approval: 2001
53002-3716-12023-06-07C16284748780-1f386c649-f82b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION. AMOXICILLIN and CLAVULANATE potassium for oral suspension, for oral use Initial U.S. Approval: 2001
53002-3716-22023-06-07C16284748780-1f386c649-f82b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION. AMOXICILLIN and CLAVULANATE potassium for oral suspension, for oral use Initial U.S. Approval: 2001
53002-3716-12023-01-30C16284748780-1f386c649-f82b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION. AMOXICILLIN and CLAVULANATE potassium for oral suspension, for oral use Initial U.S. Approval: 2001
53002-3716-22023-01-30C16284748780-1f386c649-f82b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION. AMOXICILLIN and CLAVULANATE potassium for oral suspension, for oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3716-1Amoxicillin and Clavulanate Potassium200 mL in 1 BOTTLE, PLASTICPOWDER, FOR SUSPENSION2004
53002-3716-2Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLE, PLASTICPOWDER, FOR SUSPENSION754

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3716AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [RPK PHARMACEUTICALS, INC.]4Legacy NDC, 2 package rows20230609_476ea419-8d88-40f0-a329-960e5e3859c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN476ea419-8d88-40f0-a329-960e5e3859c64
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD476ea419-8d88-40f0-a329-960e5e3859c64
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY476ea419-8d88-40f0-a329-960e5e3859c64
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY476ea419-8d88-40f0-a329-960e5e3859c64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3716-153002371601200 mL in 1 BOTTLE, PLASTIC (53002-3716-1) 200 ml2021-01-010000-00-00NoNoCurrent
53002-3716-25300237160275 mL in 1 BOTTLE, PLASTIC (53002-3716-2) 75 ml2021-01-010000-00-00NoNoCurrent