FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
67296-0904
11-digit product format
672960904
Labeler code
67296
Product ID
67296-0904_d60f6ec5-3fcb-2894-e053-2995a90af37e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA091568
Marketing category
ANDA
Marketing start
2018-01-01
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
67296-0904-12024-07-11C16284748780-11030e365-0da2-111a-e063-dadaa90a10e2amox/clav 875
67296-0904-22024-07-11C16284748780-11030e365-0da2-111a-e063-dadaa90a10e2amox/clav 875
67296-0904-12024-01-30C16284748780-11030e365-0da2-111a-e063-dadaa90a10e2amox/clav 875
67296-0904-22024-01-30C16284748780-11030e365-0da2-111a-e063-dadaa90a10e2amox/clav 875

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0904-1Amoxicillin and Clavulanate Potassium28 in 1 BOTTLETABLET, FILM COATED284
67296-0904-2Amoxicillin and Clavulanate Potassium14 in 1 BOTTLETABLET, FILM COATED144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0904AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REDPHARM DRUG, INC.]4Legacy NDC, 2 package rows20240712_7870336b-1f49-bcf4-e053-2991aa0af8b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN7870336b-1f49-bcf4-e053-2991aa0af8b74
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD7870336b-1f49-bcf4-e053-2991aa0af8b74
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY7870336b-1f49-bcf4-e053-2991aa0af8b74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-0904-16729609040128 TABLET, FILM COATED in 1 BOTTLE (67296-0904-1) 2018-01-010000-00-00NoNoCurrent
67296-0904-26729609040214 TABLET, FILM COATED in 1 BOTTLE (67296-0904-2) 2018-01-010000-00-00NoNoCurrent