AMOXICILLIN CLAV/POT

Product NDC
61919-665
11-digit product format
619190665
Labeler code
61919
Product ID
61919-665_c3de241e-6216-d6e0-e053-2a95a90a35c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMOXICILLIN CLAV/POT
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA204755
Marketing category
ANDA
Marketing start
2018-10-31
Marketing end
0000-00-00
Substance
CLAVULANATE POTASSIUM; AMOXICILLIN
Active strength
125 mg/1; mg/1
Pharmacologic classes
beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [CS]
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
61919-665-142025-01-30C16284748780-12cef2736-6e53-d83d-e063-dadaa90ab31fAMOXICILLIN/CLAV POT 875/125mg
61919-665-202025-01-30C16284748780-12cef2736-6e53-d83d-e063-dadaa90ab31fAMOXICILLIN/CLAV POT 875/125mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-665-14AMOXICILLIN CLAV/POT14 in 1 BOTTLETABLET, FILM COATED144
61919-665-20AMOXICILLIN CLAV/POT20 in 1 BOTTLETABLET, FILM COATED204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-665AMOXICILLIN CLAV/POT TABLET, FILM COATED AMOXICILLIN/CLAV POT TABLET [DIRECT RX]4Legacy NDC, 2 package rows20230421_7989371d-feed-6c25-e053-2991aa0a967d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN7989371d-feed-6c25-e053-2991aa0a967d4
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD7989371d-feed-6c25-e053-2991aa0a967d4
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY7989371d-feed-6c25-e053-2991aa0a967d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-665-146191906651414 TABLET, FILM COATED in 1 BOTTLE (61919-665-14) 2018-10-310000-00-00NoNoCurrent
61919-665-206191906652020 TABLET, FILM COATED in 1 BOTTLE (61919-665-20) 2018-10-310000-00-00NoNoCurrent