FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
67296-0123
11-digit product format
672960123
Labeler code
67296
Product ID
67296-0123_d5fb76d8-6a9b-fc0c-e053-2995a90ac479
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA065096
Marketing category
ANDA
Marketing start
2002-10-31
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
2023-12-31
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
67296-0123-12024-01-30C16284748780-11030e365-4128-111a-e063-dadaa90a10e24d995e8e-2358-26c6-e054-00144ff8d46c
67296-0123-22024-01-30C16284748780-11030e365-4128-111a-e063-dadaa90a10e24d995e8e-2358-26c6-e054-00144ff8d46c
67296-0123-32024-01-30C16284748780-11030e365-4128-111a-e063-dadaa90a10e24d995e8e-2358-26c6-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0123-1Amoxicillin and Clavulanate Potassium28 in 1 BOTTLETABLET, FILM COATED286
67296-0123-2Amoxicillin and Clavulanate Potassium6 in 1 BOTTLETABLET, FILM COATED66
67296-0123-3Amoxicillin and Clavulanate Potassium14 in 1 BOTTLETABLET, FILM COATED146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0123AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REDPHARM DRUG, INC.]6Legacy NDC, 3 package rows20220120_4d995e8e-2358-26c6-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN4d995e8e-2358-26c6-e054-00144ff8d46c6
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD4d995e8e-2358-26c6-e054-00144ff8d46c6
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY4d995e8e-2358-26c6-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-0123-16729601230128 TABLET, FILM COATED in 1 BOTTLE (67296-0123-1) 2002-10-310000-00-00NoNoCurrent
67296-0123-2672960123026 TABLET, FILM COATED in 1 BOTTLE (67296-0123-2) 2002-10-310000-00-00NoNoCurrent
67296-0123-36729601230314 TABLET, FILM COATED in 1 BOTTLE (67296-0123-3) 2002-10-310000-00-00NoNoCurrent